Job Summary: 

• Apply knowledge of applicable guidance, regulations, standards, and industry best practices to the medical device and combination product design and development process
• Prepare Human Factors Engineering documentation to support medical device and combination product development activities including design controls
• Conduct exploratory research to gather user insights and design trends and evaluate user interface concepts
• Translate user needs into user experience and interface requirements and specifications
• Develop Human Factors Product and System-level requirements in alignment with the Target Product Profile
• Execute Human Factors studies to iteratively evaluate product user interface, including hardware, software, packaging, instructional material, and training
• Conduct Task and Known Use Problem Analyses
• Support the use of safety engineering through Use-related Risk Analysis, Human Factors Validation, and regulatory Human Factors Information Requests
• Contribute to Human Factors standard operating procedures and templates development
• Collaborate with cross-functional team members from mechanical, software, clinical, regulatory, and quality engineering disciplines
• Be a part of developing the Human Factors strategy in compliance with regional regulatory guidance
• Support internal and external quality audits, communicate with internal and external key stakeholders and may also manage Human Factors, Industrial Design, and User Research vendors

Skills on Resume: 

• Regulatory Compliance (Hard Skills)
• Design Documentation (Hard Skills)
• User Research (Hard Skills)
• Interface Design (Hard Skills)
• Risk Analysis (Hard Skills)
• Cross-Functional Collaboration (Soft Skills)
• Study Execution (Hard Skills)
• Vendor Management (Soft Skills)

Job Summary: 

• Lead the User Interface development (Human Factors and Usability Engineering) of a new Inhaler Platform in line with relevant guidelines and standards
• Develop a Human Factors Strategy as a key part of the Inhaler development program to conclude with successful Design Validation
• Develop User Requirements of device, labelling and packaging elements of the combination product based on a detailed understanding of the innovator device product and the intended user profile
• Drive these User Requirements through the development program, integrating Risk Management considerations throughout the process
• Working closely with Design Engineers ensures that Industrial Design is reflective of the User Requirements and is iteratively tested throughout the inhaler development program
• Become an expert user of in-house development tools (GUI editor)
• Accompany teleoperators during trial runs and pilot projects and collect feedback for the development team
• Gather and leverage user insights and communicate design solutions to inform product development
• Sketch, visualize and prototype UI concepts and elements
• Develop a framework to measure the main operator KPIs (performance, workload, situational awareness, and usability) based on driving data and surveys
• Systematically develop and evaluate concepts and prototypes with user tests and experimental studies to improve operator KPIs
• Lead the design development of Fernride’s teleoperation human-machine interface and define design principles/ goals
• Collaborate with academia and external consultants to coordinate UI and ergonomic/ human factors expertise regarding the entire teleoperation HMI

Skills on Resume: 

• User Research (Hard Skills)
• Risk Management (Hard Skills)
• UI Development (Hard Skills)
• Prototyping (Hard Skills)
• Cross-Functional Collaboration (Soft Skills)
• Industrial Design (Hard Skills)
• Performance Evaluation (Hard Skills)
• Stakeholder Communication (Soft Skills)

Job Summary: 

• Work with other senior managers to develop and influence the strategic direction of the business and contribute to sales targets
• Proactively manage client accounts
• Work with account managers to cross-sell human factors services to existing clients
• Develop, conduct and analyse user studies and evaluations to assess the usability and safety of medical devices
• Oversee the new enquiry process, creating proposals and quotes, presenting solutions to clients, and leading the team to deliver projects
• Promote the human factors service by presenting Luto’s capabilities to potential clients
• Define system performance requirements to ensure safe and successful human operation of physical, functional, and program interfaces for pilots and maintainers
• Apply human performance principles, methodologies, and technologies to the design of human-machine systems and products
• Develop and implement research methodologies and analysis plans to test and evaluate developmental prototypes used in new products, such as cockpit hardware designs, design for maintainability, and Crew/Pilot Vehicle graphical user interfaces
• Apply a knowledge of military standards (such as MIL-STD-1472, MIL-STD-1474, MIL-STD-1787, MIL-STD-3009, MIL-STD-411F and JSSG-2010 requirements) to meet program requirements

Skills on Resume: 

• Strategic Planning (Soft Skills)
• Client Management (Soft Skills)
• Usability Testing (Hard Skills)
• Proposal Writing (Hard Skills)
• Human Performance (Hard Skills)
• System Design (Hard Skills)
• Standards Knowledge (Hard Skills)
• Cross-Selling (Soft Skills)

Job Summary: 

• Develop usability documentation for design history files, including usability plans, use specifications, task analysis, usability assessments of feature modifications, usability engineering files and reports
• Drive the early identification of user needs and potential use hazards, and collaborate with development teams to define design solutions
• Conduct regular usability testing to gather feedback from users throughout the development cycle and perform usability validations
• Understand user workflows through interviews, field observations and usability testing
• Keep pace with national and international Human Factors guidance and know how to apply it
• Contribute to internal usability best practices
• Develop creative and evidence-based solutions to complex, applied human factors challenges to develop new systems or improve existing ones  
• Lead or contribute within multi-disciplinary teams, accomplishing human factors engineering activities involving representative end-users of systems, cognitive scientists, designers, software developers, and program stakeholders 
• Plan and execute human factors research efforts including the development of user personas, the articulation of complex workflows, and the analysis of use-case environmental conditions 
• Document research, analysis, findings, and recommendations in human factors engineering artifacts and products 

Skills on Resume: 

• Usability Testing (Hard Skills)
• Task Analysis (Hard Skills)
• Workflow Research (Hard Skills)
• Regulatory Knowledge (Hard Skills)
• Creative Problem-Solving (Soft Skills)
• Cross-Functional Collaboration (Soft Skills)
• Persona Development (Hard Skills)
• Documentation Skills (Hard Skills)

Job Summary: 

• Develop creative and evidence-based solutions to complex, applied human factors challenges to develop new systems or improve existing ones 
• Lead or contribute in multi-disciplinary teams, accomplishing human factors engineering activities involving representative end-users of systems, cognitive scientists, designers, software developers, and program stakeholders  
• Plan and execute human factors research efforts including the development of user personas, the articulation of complex workflows, and the analysis of use-case environmental conditions
• Document research, analysis, findings, and recommendations in human factors engineering artifacts and products
• Clearly understand design and interaction challenges by working closely with engineers and designers
• Collaborate cross-functionally to identify the study goal and to develop a study plan for the goal
• Identify critical attributes for data collection and manage data collection tools and processes
• Conduct statistical (qualitative and quantitative) analysis of data to formulate insights
• Visualize data and findings to deliver results to stakeholders
• Cutting-edge research into new and novel technologies
• Developing Human Machine Interfaces
• Carrying out human-in-the-loop assessments in high-fidelity simulators on site at Warton
• Working with subject matter experts and end users, including pilots, maintainers, trainers or support specialists, and much more

Skills on Resume: 

• Human Factors Research (Hard Skills)
• Cross-Functional Collaboration (Soft Skills)
• Workflow Analysis (Hard Skills)
• Data Visualization (Hard Skills)
• Statistical Analysis (Hard Skills)
• HMI Development (Hard Skills)
• Creative Thinking (Soft Skills)
• Stakeholder Engagement (Soft Skills)

Job Summary: 

• Provide specialist HF advice and support to Inova Health System as a quality division member
• Develop and implement a range of HF initiatives that support work around safe systems, teamwork work and system design, to be developed and implemented in partnership with clinical teams and the project lead, is of vital importance
• Conduct hierarchical task analysis, complex system models, task/cognitive analysis, work domain analysis and product evaluation across a range of projects
• Support for the tests campaign
• Interface with certification authorities for system approval
• Foster implementation of the Human Centered Design concept
• Establish and maintain the philosophies and principles of operation of Flight Decks
• Plan, document, execute and scale HF activities on multiple projects with cross-functional teams
• Activities may include ethnographic research, requirements definition research, task analysis and use-related risk analysis (aFMEA/uFMEA), formative evaluations, final HF validation / summative evaluations, and analysis of market feedback
• Analyze study data, perform root cause analysis, and write study reports
• Present user interface design recommendations based on user feedback, empirical data, literature searches, and industry best practices to large teams
• Shape HF processes and ensure compliance to the latest HF/usability standards and guidances
• Prepare and review documentation for submission to regulatory agencies and notified bodies
• Answer questions and provide rationales 

Skills on Resume: 

• Task Analysis (Hard Skills)
• System Evaluation (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Root Cause Analysis (Hard Skills)
• Human-Centered Design (Soft Skills)
• Cross-Functional Planning (Soft Skills)
• Study Reporting (Hard Skills)
• Stakeholder Communication (Soft Skills)

Job Summary: 

• Develop and maintain the vehicle package drawings and associated dimension database
• Perform physical and digital benchmarking analyses and maintain the benchmark dimension database
• Develop, validate, and ensure compliance with ergonomics criteria and attributes
• Lead user/customer clinics to confirm compliance with ergonomic targets
• Provide technical oversight to cross-functional teams
• Regularly communicate the human factors process and perspectives to internal and external stakeholders
• Design, execute, and report on early-stage research (contextual inquiry) through user validation research (summative) on physical and/or digital products
• Translate results of research into actionable design recommendations, and draft/contribute to human factors documents, such as task analyses, uFMEA, use specification, and HFU/UE reports
• Ensure that FDA and global usability regulatory standards such as IEC 62366-1: 2015, ANSI/AAMI HE75, and MDR, are being met and that project teams are working within these standards and guidelines
• Interact with a wide range of user groups (from patients to surgeons) in a variety of use environments
• Assist the team in preparing Human Factors Engineering proposals and budgets

Skills on Resume: 

• Ergonomics Compliance (Hard Skills)
• Benchmark Analysis (Hard Skills)
• User Research (Hard Skills)
• Design Recommendations (Hard Skills)
• Regulatory Standards (Hard Skills)
• Cross-Functional Oversight (Soft Skills)
• Stakeholder Communication (Soft Skills)
• Proposal Preparation (Soft Skills)

Job Summary: 

• Contributing to nuclear system designs and safety cases, and multidisciplinary reviews of existing designs
• Ensuring timely Human Factors integration into equipment and system design projects
• Undertaking and reporting Human Factors assessments to inform both design and safety assessments, providing sound ergonomic design advice and clear recommendations
• Apply human performance principles, methodologies, and technologies to the design and development of air vehicle Crew Stations, Maintainer Geometry, and layout of controls and displays
• Work closely with Bell engineering leaders to establish system design, operating, and training requirements to ensure optimized human-machine interfaces
• Identify and analyze technological problems or risks, perform theoretical human factors investigations, develop and implement research and analysis plans
• Develop and design menus, logic and display graphics for the pilot vehicle Interface
• Evaluate design and layout in physical and electronic mockups, simulators and air vehicles
• Produce requirements specification documents

Skills on Resume: 

• System Design (Hard Skills)
• Safety Assessment (Hard Skills)
• Ergonomic Analysis (Hard Skills)
• Crew Interface (Hard Skills)
• Risk Evaluation (Hard Skills)
• Mockup Testing (Hard Skills)
• Cross-Functional Coordination (Soft Skills)
• Requirements Documentation (Hard Skills)

Job Summary: 

• Provides domain-specific expertise and overall Human Factors Design leadership and perspective to cross-organization projects, programs, and activities
• Conducts studies by applying usability testing, field research, surveys, diary studies, and any other methods that can inform product design decisions and improve user experience
• Defines the research objectives and formulates research proposals to inform specific design decisions
• Participates as one member of a project team of Industrial Designers, Ux Designers and internal and outsourced design and development partners to develop holistic, high-quality hardware experience solutions for complex projects and products
• Reviews and evaluates designs and project activities for compliance with experience objectives, regulatory guidelines, and development guidelines and standards
• Provides tangible feedback to improve product quality and user experience
• Leads and supports project teams of other designers and internal and outsourced partners to drive innovation and integration of new technologies into projects and activities in the design organization
• Contributes to design expertise by actively participating in various product discussion sessions with the product designers, engineers, developers, and other subject matter experts
• Participates in developing a customer-centric culture by sharing insights coming from research projects and evangelizing the best research methods

Skills on Resume: 

• Usability Testing (Hard Skills)
• Research Planning (Hard Skills)
• Design Leadership (Soft Skills)
• User Experience (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Team Collaboration (Soft Skills)
• Technology Integration (Hard Skills)
• Stakeholder Engagement (Soft Skills)

Job Summary: 

• Works as a trusted advisor with the customer in identifying business problems and use cases across multiple communication technologies including Social Media, Messaging, Video, Chat, Email, SMS, and Voice
• Provides thought leadership in the strategic design process and translates business needs into optimal user interface designs, preparing user interface documentation for developers and assisting with the development of test plans
• Enhances existing systems by analyzing and identifying areas for improvement/modification
• Possesses project leadership responsibilities for complex projects
• Assists in establishing and applying software design/usability best practices for user interfaces
• Meets customer and business goals as an individual and a member of a cross-functional project team
• Gathers and analyzes caller and business requirements used to design successful applications
• Creates user interface requirements documents, functional specifications and other business-related documents
• Develops and presents call flow and messaging to accomplish business and caller satisfaction goals
• Consults with (internal and/or external) customers on the branding of custom applications (including, for example, analysis of a customer’s marketing strategy and touch-points), resulting in the development of corresponding personas
• Helps customers select voice talent in line with the persona developed
• Coaches voice talent during message recording sessions
• Collaborates with solution architects and developers to ensure compliance with application design objectives
• Provides usability support to product teams, including the analysis and investigation of applications/systems, including graphical, web, multimedia, voice response, and conversational user interfaces
• Supports and executes speech application tuning optimization including both speech-recognition and caller experience optimization
• Supports and executes TTS tuning to optimize segment selection and transitions
• Exercises judgment in methods, techniques, and evaluation criteria for obtaining exceptional results
• Collaborates closely with other team members in a virtual work environment
• Demonstrates problem-solving and lateral thinking as part of a team, or individually
• Contributes to the development of company objectives and principles and achieves goals in creative and effective ways
• Shares new knowledge and lessons learned as training for other team members
• Mentors others as a technical subject matter expert
• Translates complex concepts and designs into simple-to-follow examples

Skills on Resume: 

• User Interface Design (Hard Skills)
• Business Analysis (Hard Skills)
• Cross-Functional Collaboration (Soft Skills)
• Voice Interaction (Hard Skills)
• Strategic Consulting (Soft Skills)
• Project Leadership (Soft Skills)
• Usability Optimization (Hard Skills)
• Mentoring Skills (Soft Skills)

Job Summary: 

• Support regulatory-required research activities and develop user-friendly products on the leading edge of Healthcare and AI
• Focuses on planning and conducting remote studies, including formative and summative/human factors validation studies
• Assist with use specifications, task analyses, use-related risk assessments, and project logistics
• Plan and conduct remote formative and usability studies
• Participate in risk analysis and critical task development
• Plan and conduct remote summative studies
• Analyze study findings, create detailed reports, and present to stakeholders
• Assist other Human Factors Engineers on larger projects (via recruitment, data analysis, etc.)
• Design and implement user interfaces for autonomous systems
• Architect, implement, and maintain data extraction and user interaction tools for both the frontend and backend
• Implement APIs for developers to use and extend current functionalities
• Work with relevant stakeholders to ensure adherence to User Interface Designs
• Work with Systems Engineers to develop User Interface Requirements
• Interface with Customers and End Users to constantly improve the designs
• Identify performance bottlenecks and safety issues in the system, benchmark different methods and provide solutions

Skills on Resume: 

• Usability Studies (Hard Skills)
• Risk Assessment (Hard Skills)
• Data Analysis (Hard Skills)
• UI Design (Hard Skills)
• API Development (Hard Skills)
• Cross-Team Collaboration (Soft Skills)
• Stakeholder Communication (Soft Skills)
• System Optimization (Hard Skills)

Job Summary: 

• Provides technical guidance and/or design expertise to a wide variety of contexts
• Supports and/or directs R&D,  Clinical, Marketing, and other staff regarding human factors considerations
• Supports and/or directs the definition and development of system user interface design(s)
• Support the definition and development of labeling and training
• Contributes to user interface designs by providing guidance, ideas, and reviews to UX designers and developers
• Collaborates with peers and other staff on human factors processes and principles
• Ensures that development plans, processes and activities address human factors engineering process and design requirements to maximize product usability and use-related safety
• Identifies user needs/requirements, and collaborates with marketing to ensure designs meet the user and customer needs
• Collaborates with development teams to optimize designs in consideration of use error risk and overall usability, and participates in the identification, analysis, and evaluation of use-related risk and the development of risk controls
• Responsible for planning and conducting human factors analyses, unstructured testing, and structured usability studies
• Involve collaboration with others or personally executing study/protocol design, study execution, data collection and analysis, as well as writing study reports and communicating findings and recommendations to teams
• Contributes to the design development process by participating in design review meetings, reviewing and contributing to design inputs, risk analysis, and reviewing and testing new product performance
• Applies persuasion to change the thinking of and/or gain acceptance from others in sensitive situations while maintaining an effective working relationship
• Oversees the monitoring, completion, and accuracy of documents produced by human factors engineering activities
• Responsible for HF assessments included in regulatory documents submitted to the FDA (or other regulatory bodies)
• Responsible for ensuring compliance with applicable standards and guidance
• Contributes to human factors process development and improvements and development of associated templates
• Responsible for keeping current on new developments in human factors engineering
• Works on problems of moderate scope where analysis of the situation or data requires a review of a variety of factors
• Exercises judgment within defined procedures and practices to determine appropriate action
• Builds productive working relationships
• Escalates issues to the supervisor/manager for resolution
• Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations

Skills on Resume: 

• Usability Studies (Hard Skills)
• Risk Mitigation (Hard Skills)
• Design Review (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Cross-Department Collaboration (Soft Skills)
• Persuasive Communication (Soft Skills)
• Process Improvement (Soft Skills)
• Documentation Oversight (Hard Skills)

Job Summary: 

• Provide expert input to the device development teams to establish system, design, and operating requirements, support the design of packaging, labelling, and user interface
• The candidate will be responsible for independently leading, planning, executing, and reporting human factors studies with users to evaluate the user interface design and propose improvements
• Roll out the Human Factors strategy by planning the activities accordingly and performing/documenting the planned activities (e.g., user studies, design input)
• Communication and negotiation skills are key to influencing diverse stakeholders
• Provides human factors support throughout the product development lifecycle
• Identify user needs, development of user profiles and use scenarios, task analysis, use-related risk analysis, generation of hardware and software design concepts, generation of instructions for use (creation of graphical user interfaces, and product graphics)
• Design the user interface and instructions for use
• Plans and executes formative and summative user studies, reporting and presenting design recommendations to the project team either using external vendors or using internal facilities
• Design Instruction for Use and User Interface
• Performs anthropometric, biomechanical, ergonomic, and systems safety analyses to identify and assess risk in product development.
• Propose design optimization of the developed product

Skills on Resume: 

• User Study Execution (Hard Skills)
• UI Design (Hard Skills)
• Risk Analysis (Hard Skills)
• Design Optimization (Hard Skills)
• Stakeholder Communication (Soft Skills)
• Formative Evaluation (Hard Skills)
• Human Factors Strategy (Soft Skills)
• Instructional Design (Hard Skills)

Job Summary: 

• Responsible for constructing the directives for use and the user interface
• Recognise and evaluate risk in product development
• Conduct anthropometric, biomechanical, ergonomic, and systems safety examinations
• Suggest design optimisation of the emerged product
• Plan and implement formative and summative user studies, document and display design suggestions to the project team either by using suppliers on an external basis or using amenities on an internal basis
• Write and evaluate human factors (HF) requirements to maximize astronaut safety, comfort, and the astronaut experience
• Develop HF verification plans
• Perform HF analyses (e.g., task and human error analyses)
• Provide HF and ergonomics design support to Blue Origin’s design teams
• Evaluate the design of astronaut-facing and ground crew-facing aspects of Blue Origin’s spacecraft systems
• Design and run human-in-the-loop tests
• Act as a technical liaison between the systems engineering, design, and operations teams

Skills on Resume: 

UI Development (Hard Skills)

Risk Evaluation (Hard Skills)

Ergonomic Analysis (Hard Skills)

Design Optimization (Hard Skills)

HF Requirements (Hard Skills)

Human-in-Loop Testing (Hard Skills)

Cross-Team Liaison (Soft Skills)

Formative Studies (Hard Skills)

Job Summary: 

• Identify unmet needs and generate design requirements while ensuring human factors and usability regulatory requirements are met
• Lead ethnographic research activities that will craft and define business strategies across a variety of medical device products and services
• Contribute to the establishment and adoption of organizational human factors operating procedures and processes
• Lead research across multiple programs to understand users (clinicians and lay users), use environments, user characteristics, behaviors and constraints
• Support the delivery of projects by developing and leading strategies, informing design through user research, reviewing HF literature, iteratively testing concepts, leading external partners and compiling reports for submission to regulatory authorities
• Provide ongoing assessment where changes to an existing product user interface are proposed, identifying any additional work
• Develop and maintain Usability processes and procedures to streamline product development and maintain regulatory compliance
• Develop and maintain an understanding of the latest information regarding Usability and Human Factors testing for medical devices
• Maintain a network of external contacts who can be referred to for advice 
• Ensure all activities are performed by relevant national and international standards
• Place special emphasis on NMPA Human Factors Guidance, IEC62366-1, and the FDA’s guidance Applying Human Factors and Usability Engineering to Medical Devices

Skills on Resume: 

• User Research (Hard Skills)
• Design Requirements (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Process Development (Soft Skills)
• Ethnographic Studies (Hard Skills)
• Literature Review (Hard Skills)
• Partner Management (Soft Skills)
• Standards Knowledge (Hard Skills)

Job Summary: 

• Leads and coordinates internal and external Human Factors program stakeholders
• Identifies and tasks stakeholders to accomplish program goals
• Provides primary communication and coordination across multiple disciplines and stakeholders
• Engages customers, operators, regulators, industry specialists, suppliers, and internal disciplines to identify and clarify operational requirements to support equipment design throughout the design process
• Applies structured methods to develop Human Factors requirements and coordinates those requirements and their implementations with the system design process
• Develops and performs early-phase development methods, such as pilot-in-the-loop simulations and other early-stage prototyping, to validate requirements
• Creates methods for and conducts pilot workload assessments to evaluate tasking and validate requirements, particularly in support of a safety assessment process
• Develops and supports the development of multiple structured methods
• Verify the implementation of HF requirements including flight testing, human-in-the-loop simulation, and modeling techniques
• Produces test plans, reports and/or memos to substantiate compliance with human factors certification regulations

Skills on Resume: 

• Stakeholder Coordination (Soft Skills)
• Operational Requirements (Hard Skills)
• HF Requirements (Hard Skills)
• Workload Assessment (Hard Skills)
• Prototyping Methods (Hard Skills)
• Flight Testing (Hard Skills)
• Certification Support (Hard Skills)
• Cross-Disciplinary Communication (Soft Skills)

Job Summary: 

• Provide human systems expertise and support to the design and development of human-to-system interfaces in an integrated and collaborative fashion, supporting design, development, and preparation of deliverables
• Conduct cognitive task analysis - system and component level
• Perform human error analysis by identifying potential sources of human error and actions to mitigate sources of human error through design recommendations
• Conduct Human-in-the-Loop (HITL) testing by developing test plans, coordinating with facilities, and collaborating with subject matter experts
• Conduct the data collection and analysis, and deliver presentations to program management throughout the design lifecycle
• Provide human factors consulting services to include design, prototyping, surveys/interviews, heuristic evaluation, cognitive walkthroughs, and/or usability testing of human-system interfaces
• Provide verification planning and execution for usability, workload, anthropometry, range of motion, strength, etc.
• Support technical reviews such as Preliminary Design Reviews (PDR) and Critical Design Review (CDR)
• Apply human factor principles and knowledge to capture user requirements and support the design, development, testing, and evaluation of safe and effective user interfaces
• Utilize user-centered design tools and methods for cognitive task analysis, crew workload analysis, usability evaluation, statistical and human error analysis
• Work with UI/UX engineers to develop Human-Machine interfaces to ensure human engineering requirements are met by the design
• Review and evaluate the Human-Machine interface design and provide feedback
• Develop a compliance plan for human factor considerations
• Manage review of certification deliverables related to human factor evaluation with the certification authority
• Develop human factor standards and other guidance documents to support Human-Machine interface design

Skills on Resume: 

• Cognitive Analysis (Hard Skills)
• Human Error Assessment (Hard Skills)
• HITL Testing (Hard Skills)
• UI Prototyping (Hard Skills)
• Design Compliance (Hard Skills)
• User-Centered Design (Hard Skills)
• Stakeholder Presentation (Soft Skills)
• Certification Review (Hard Skills)

Job Summary: 

• Collaborate with design teams to incorporate Human Factors Engineering (HFE) input into vehicle design
• Conduct HFE analyses to support recommendations for design changes
• Evaluate customer requirements for HFE and determine vehicle compliance
• Support the System Engineering Department in the development of the System Specification Document
• Plan and conduct HFE testing to determine compliance with the contract and/or System Specification Document
• Generate HFE reports to be submitted to the Customer
• Create and manage Human/System Interface Databases, Hazard Logs, Risk Registers and manage Hazard Tracking
• Providing support throughout the product development life cycle including user needs identification, development of user profiles and use scenarios, task analysis, use-related risk analysis etc.
• Coordinating formative and summative user studies, reporting and presenting design recommendations to the project team
• Designing instructions for Use and User Interface
• Conducting anthropometric, biomechanical, ergonomic, and systems safety analyses to identify risk in product development and propose design optimisation

Skills on Resume: 

• HFE Analysis (Hard Skills)
• System Specification (Hard Skills)
• Risk Management (Hard Skills)
• User Study Coordination (Hard Skills)
• UI Design (Hard Skills)
• Design Compliance (Hard Skills)
• Team Collaboration (Soft Skills)
• Documentation Reporting (Hard Skills)

Job Summary: 

• Develop human factors (HF) engineering strategies
• Lead HF activities on drug-device combination product program teams, including ethnography, heuristic analyses, requirements definition research, use-related risk analysis, formative usability studies and validation usability studies based on user needs and usability guidance principles
• Author, review and edit study protocols and reports, research summaries, usability requirements and design control documentation
• Perform task analysis, usability-related risk analyses, interface evaluations and provide design recommendations
• Conduct and be responsible for user inquiries, user studies, data gathering and data analysis
• Work with other HF team members to develop and implement HF process improvements
• Lead activities in the product design process by applying ergonomic and usability design principles to the YETI product design
• Work collaboratively with Industrial Design, Advanced Technology, Product Management and business peers to propose the best experience for the end user
• Develop and maintain design specifications and other design documentation that will be used as guidance for cross-functional team members
• Utilize ideation skills to effectively communicate design ideas to others
• Conduct usability studies of the prototype and existing designs during various phases of concept and product development
• Translate study results into actionable design recommendations and product requirements
• Understand target audiences’ needs and other motivating factors and translate them into concepts for comfortable, compelling and competitive product experiences
• Plan and execute iterative user research and analysis projects including but not limited to task analysis, competitive assessments, benchmarking, customer interviews, concept testing and usability testing
• Identify user insights and lead new initiatives to deliver industry-leading user experiences

Skills on Resume: 

• HF Strategy (Hard Skills)
• Usability Testing (Hard Skills)
• Risk Analysis (Hard Skills)
• Design Documentation (Hard Skills)
• Cross-Team Collaboration (Soft Skills)
• User Research (Hard Skills)
• Ideation (Soft Skills)
• Process Improvement (Soft Skills)

Job Summary: 

• Provide Human Factors Engineering support across the product development lifecycle including support for customer and user needs definition, development of user and environment profiles, use and workflow scenarios and task analyses
• Own the usability testing, user error/risk analysis, and human factors related post-launch activities while participating in the development of software requirements specification, user interface design,
• Perform Human Factors Engineering and User Experience activities within the framework of a regulated environment and in partnership with Clinical and Regulatory Affairs
• Provide human factors expertise across the product portfolio including identifying, planning, monitoring, and executing Human Factors studies and other activities
• Provide in-house training and champion the importance of human factors engineering
• Work closely with the Clinical Science team and other departments (marketing, product planning, engineering) throughout the design and development process to not only meet user needs but also factor in business priorities and constraints
• Plan and conduct end-user evaluations of product concepts, analyze data, document evaluation methods and results, and applicable design validation activities
• Provide oversight and collaborate with external resources to execute human factors activities on projects
• Lead usability study participant recruitment and any necessary IRB submissions, or oversee external recruiting resources to do the same 
• Gather, clarify and prioritize key questions from the product team to help define, plan, and execute research from concept testing through launch
• Deliver high-quality research insights, conveyed in clear and concise presentations/reports
• Present insights to the product development team, including Product Managers and Designers, while finding other creative ways to share insights
• Partner with Product Managers, User Experience Designers, Industrial Designers, Data Analysts, Go-to-Market, and the Beta team to plan research and ensure work is impacting product decisions
• Based on research insights, build and document foundational knowledge and learnings to be leveraged for future product designs
• Be an advocate for the Sonos customer and product research

Skills on Resume: 

• Usability Testing (Hard Skills)
• Risk Analysis (Hard Skills)
• Cross-Functional Collaboration (Soft Skills)
• Regulatory Compliance (Hard Skills)
• User Research (Hard Skills)
• Training Delivery (Soft Skills)
• Insight Presentation (Soft Skills)
• Research Planning (Hard Skills)

Job Summary: 

• Ensure the smooth and effective integration of human factors throughout design, development and implementation
• Produce a human factors integration plan to ensure HF methods and activities are suitably integrated with other project activities and conducted at the appropriate time, using suitable methods
• Apply human factors methods and design principles, and the company's process 
• Compliance with relevant human factors standards and good practice
• Attend and chair customer and user group sessions to obtain feedback on the proposed user interfaces
• Participate in the formal reviews of project or product documentation, as required by the company process
• Participate in project meetings (e.g., milestone reviews, change control board, progress reviews, etc)
• Deliver high-quality deliverables to record human factors activities and provide evidence of compliance with human factors processes and client standards
• Assist in the development of a Company database of human factors-related data for use by future projects

Skills on Resume: 

• HF Integration (Hard Skills)
• Standards Compliance (Hard Skills)
• UI Feedback (Soft Skills)
• Process Participation (Soft Skills)
• Design Principles (Hard Skills)
• Documentation Review (Hard Skills)
• Meeting Engagement (Soft Skills)
• Data Management (Hard Skills)

Job Summary: 

• Provide Human Factors support throughout the product development process 
• Manage small to medium-sized research projects, overseeing teams of researchers and ensuring the project is delivered to timescales and budget
• Oversee and review the work of less-experienced Human Factors engineers and serve as a mentor to those working in the discipline
• Involved in promoting Human Centered Design within projects
• Developing these activities in the context of large development programs
• Working collaboratively with other functions, including marketing, engineering, industrial design, manufacturing, quality and regulatory, to produce human-centered solutions that meet user needs
• Act as the first point of contact for both clients and colleagues on all aspects related to human-centered design
• Serve as a resource for business developers to help define work plans, scope, and budget for proposed projects and participate in prospective client meetings
• Apply user-centered design methods to translate user needs, business objectives, and technology capabilities into exceptional user experiences
• Conduct user interviews and observations to elicit requirements
• Design, prototype, recommend, and evaluate user experiences for a variety of system types on a variety of platforms
• Advise MITRE and sponsors on emerging technologies to improve collaboration and knowledge sharing in the workplace

Skills on Resume: 

• Project Management (Soft Skills)
• Human-Centered Design (Hard Skills)
• User Research (Hard Skills)
• Mentorship (Soft Skills)
• Cross-Functional Collaboration (Soft Skills)
• UX Prototyping (Hard Skills)
• Client Engagement (Soft Skills)
• Technology Advising (Hard Skills)

Job Summary: 

• Implement Cook’s risk management procedures throughout the product lifecycle to create/update risk management documents
• Guide a representative of the risk management team to other departments that need to make risk-based decisions by facilitating the implementation of Cook’s risk management procedures
• Assess and document product risk during new product development, manufacturing, and post-market surveillance, and drive continuous improvement efforts by working with associates from engineering, quality, medical affairs and regulatory
• Help develop quality system procedures that are compliant with relevant standards and regulations including but not limited to ISO 14971, ISO 13485, 21CFR, IEC 62366, HE75, and EU MDR
• Identify opportunities for improvement based on feedback from internal customers, as well as other users of the risk management system
• Support the development and implementation of production controls. (e.g., qualification, process capability, sampling plans, validation, etc.)
• Support investigation of product non-conformance/complaints, root cause analysis, monitoring/trending of process and product, and escalation of identified issues
• Plan, draft, review, and approve change requests
• Interface with internal or 3rd party auditors (e.g, FDA, Notified Body, etc.)
• Perform work per external and internal quality standards
• Interface with internal and external groups on quality-related issues
• Maintain knowledge of current regulatory requirements and standards as they pertain to the development and release of medical devices and support the understanding of medical device regulations and best practices within Cook
• Planning, scaling, documenting, and executing human factors project activities per IEC62366
• Work with cross-functional teams and provide Human Factors support through the entire product development life cycle
• Define and document workflows, user-related tasks and scenarios related to product use
• Evaluate, assess, and document risks related to product use
• Design usability evaluations to ensure user interface requirements are met, risk controls about use have been applied and are effective 
• Manage conflict resolution as it relates to technical situations

Skills on Resume: 

• Risk Management (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Root Cause Analysis (Hard Skills)
• Change Management (Hard Skills)
• Usability Evaluation (Hard Skills)
• Cross-Functional Collaboration (Soft Skills)
• Process Improvement (Soft Skills)
• Audit Interface (Soft Skills)

Job Summary: 

• Meet with clients to learn about new technologies and interpret client needs for consultation on usability engineering
• Contribute to marketing and proposal development activities
• Perform task analyses and user research studies for new medical device concepts
• Author and update usability risk analyses in collaboration with coworkers and clients
• Author formative and summative usability study protocols
• Plan and coordinate usability studies, including gathering equipment, designing and preparing study models, and coordinating with recruiters
• Moderate formative and summative usability studies and/or record data
• Perform data analysis and analysis of usability study video footage to identify the root cause of observed use errors
• Prepare and/or assist with formal usability study reports
• Create usability engineering documentation
• Conduct above technical work on projects with minimal guidance and within time, budget and quality system constraints
• Support both formal and informal communications and relationships with clients including responsibility for reports and presentations
• Contribute to user interface designs by providing guidance, ideas, and feedback to clients and conducting usability studies

Skills on Resume: 

• Client Consultation (Soft Skills)
• Usability Studies (Hard Skills)
• Task Analysis (Hard Skills)
• Risk Documentation (Hard Skills)
• Data Analysis (Hard Skills)
• Study Moderation (Hard Skills)
• UI Feedback (Soft Skills)
• Proposal Development (Soft Skills)

Job Summary: 

• Acts as a subject matter expert for systems of responsibility
• Assist with or lead various projects as assigned by a direct supervisor
• Coordinates with appropriate departments, resources, and/or outside services to prepare design modifications, clarify problems and develop designs for systems or responsibilities
• Designs and develops products that meet approved User Inputs, support business and market strategies, and are intended to generate revenue growth
• Lead teams to develop, improve, modify, and replace systems or sub-system elements for systems of responsibility
• Develops and establishes detailed Engineering Input specifications to ensure product function and cost-effective manufacturing
• Oversees the development of custom equipment to support small-scale product assembly and testing
• An expected contributor to the generation of ideas and potential inventions
• Maintains a safe work environment for self and other employees
• Maintains a clean work area
• Mentor other staff, position subordinates for promotion and increase overall department/group expertise

Skills on Resume: 

• System Design (Hard Skills)
• Project Leadership (Soft Skills)
• Cross-Department Coordination (Soft Skills)
• Engineering Specifications (Hard Skills)
• Product Development (Hard Skills)
• Innovation Contribution (Soft Skills)
• Team Mentorship (Soft Skills)
• Safety Compliance (Hard Skills)

Job Summary: 

• User Research assisting in designing, executing, and reporting on early-stage research (contextual inquiry) through user validation research (summative) on physical and/or digital products
• Translating results of user research into actionable design recommendations
• Contributing to HF documentation (task analysis, uFMEA, use specification, etc.)
• Communicating HFE perspectives to cross-functional teams
• Working within existing FDA/International HF standards and guidelines
• Interacting with a wide range of study participants, from patients to surgeons, in a wide range of use environments
• Use significant expertise in design thinking, human factors and usability engineering to design products and solutions used by patients in the area of cancer treatment
• Develop user requirements through interviews and focus group techniques
• Analyze data both qualitatively and quantitatively, prepare detailed reports and presentations to support the final design proposal
• Influence the organization through thoughtful ideas and presentations that balance feasibility and desirability whilst maintaining patient safety and performance
• Select and manage a small network of carefully chosen external partners

Skills on Resume: 

• User Research (Hard Skills)
• Design Recommendations (Hard Skills)
• HF Documentation (Hard Skills)
• Cross-Team Communication (Soft Skills)
• Standards Compliance (Hard Skills)
• Data Analysis (Hard Skills)
• Design Thinking (Soft Skills)
• Vendor Management (Soft Skills)

Job Summary: 

• Provide subject matter expertise in human factors engineering across the organisation
• Ensure effective implementation of human factors as per the project human factors implementation plan & aligned with AS7470
• Engage/manage/provide evidence to stakeholders concerning human factors
• Undertake engagement with safety regulatory bodies
• Provide support to risk assessment workshops on a basis
• Help support the delivery of design packages with input into the HF aspects of the design
• Conduct/lead/facilitate all related activities under the HFIP/HFMP and EHFA
• Provide SFAIRP arguments to the assurance case
• Provide input into the design solutions
• Provide SME advice to MOC/EC requests before submittal to BU
• Input into new maintenance/operational procedures/plan
• Provide SME support to risk assessment workshops
• Participate in preparation for Day One, including but not limited to input into the training needs analysis, user acceptance testing, HF support during commissioning, verification and validation requirements, Post implementation review MoC Form 3, and collection of HF lessons learned

Skills on Resume: 

• HF Implementation (Hard Skills)
• Regulatory Engagement (Soft Skills)
• Risk Assessment (Hard Skills)
• Design Input (Hard Skills)
• Stakeholder Management (Soft Skills)
• Assurance Support (Hard Skills)
• Procedure Development (Hard Skills)
• Lessons Learned Review (Soft Skills)

Job Summary: 

• Conducting Workload Analysis / Assessment of Situation Awareness to optimise operator performance through design
• Undertaking Human Reliability Analysis (Qualitative and Quantitative) and Human Factors support to the Safety Case
• Planning and conducting User Trials and HF assessments of the developing design, optimising user interaction
• Conducting Human Machine Interface reviews
• Design and assessment of the workplace, accommodation and habitable environments, 
• Design Control Room and Work Station
• Design Experimental including User Trials and Interface design using Human Factors disciplines of Anthropometry, Human Computer Interaction (HCI), Human Machine Interface (HMI) and Human Reliability Assessment (HRA)
• Be part of a large Human Factors department, reporting to the Human Factors Managers
• Work closely with stakeholders including Engineers, Designers, Safety Case Teams, End Users and Client Representatives
• Work well in a multi-disciplinary environment and collaborate on resolving complex enterprise solutions
• Develops positive relationships with other engineering disciplines and other functions, such as sales, manufacturing, and marketing, to support client needs
• Prepare discussion protocols and conduct direct research with customers and end-users
• Conduct analysis of workflows, journey mapping as well as persona needs and challenges
• Exercises judgment in selecting research methodologies and techniques that best address program needs
• Provide user perspective and outline recommendations to improve solution performance and identify design opportunities

Skills on Resume: 

• Workload Analysis (Hard Skills)
• HMI Design (Hard Skills)
• User Trials (Hard Skills)
• Human Reliability (Hard Skills)
• Multidisciplinary Collaboration (Soft Skills)
• Stakeholder Engagement (Soft Skills)
• Workflow Mapping (Hard Skills)
• Design Recommendations (Soft Skills)

Job Summary: 

• Undertake user research, such as ethnography in healthcare or consumer settings, focus groups, preference tests, and usability tests (both formative and summative)
• Develop research materials, such as protocols, scripts, and data collection instruments
• Analyze research data and produce deliverables suitable for Human Factors/Usability Engineering files
• Implement a variety of user-centered design methods, such as workflow analysis and personas
• Optimize user interface design by integrating usability and ergonomics
• Work on interdisciplinary teams with designers and engineers to analyze and evaluate data, conduct HF evaluations, and generate concepts, product specifications, and usability goals
• Manage outside suppliers for participant recruiting and research facilities, language translation, etc
• Provide accurate, well-defined, and articulate verbal and written presentations to clients
• Interact with the user interface, engineering, operations, business development, and quality disciplines to develop good processes, close working relationships, and successful products
• Contact with clients regarding deliverables and general project communications

Skills on Resume: 

• User Research (Hard Skills)
• Data Analysis (Hard Skills)
• UI Optimization (Hard Skills)
• Workflow Analysis (Hard Skills)
• Cross-Functional Collaboration (Soft Skills)
• Supplier Management (Soft Skills)
• Client Communication (Soft Skills)
• Presentation (Soft Skills)

Job Summary: 

• Represent R&D in cross-functional programs, provide direction and observations on internal customer objectives
• Support the evaluation of new technologies
• Independently implement complex concepts, draft design documentation, plan and conduct relevant tests
• Participate in, solicit feedback, and document reports on cadaveric evaluations
• Work under supervision with surgeon customers in a user setting, clearly communicate design goals and incorporate feedback into designs
• Support for the design of architectural concepts under close professional leadership
• Independently integrate and administer development tools including validation
• Support maintenance and improvement of engineering methods and practices
• Support training and mentoring activities regarding established engineering best practices, design principles, processes and tools
• Work with the core team to determine project schedules and time commitments of self and other functional project team members and communicate status of assignments to project management
• Design and implement solutions to address identified problems

Skills on Resume: 

• Technology Evaluation (Hard Skills)
• Design Documentation (Hard Skills)
• User Feedback Integration (Soft Skills)
• Validation Testing (Hard Skills)
• Engineering Methods (Hard Skills)
• Cross-Functional Support (Soft Skills)
• Mentorship Support (Soft Skills)
• Problem Solving (Soft Skills)

Job Summary: 

• Performing Crew Task Analysis, Crew Worksite Analysis, Crew Operating Loads Analysis, Crew Anthropometrics Analysis, and Human Systems Integration
• Performing or supporting Human Error analysis
• Providing expertise in design for crew interaction/operability of vehicle flight displays and controls
• Providing expertise for human-in-the-loop planning and testing
• Providing expertise in human factors/usability evaluations
• Performing or supporting Ionizing Radiation Exposure Analysis (IREA)
• Performing or supporting lighting requirements, lighting simulations, and lighting testing
• Assessing the suitability and feasibility of exercise accommodations
• Performing predictive lighting modeling and analysis
• Performing task assessment analysis
• Work closely with design and systems engineering to determine architectures, systems concepts, and design solutions based on evaluation of performance specifications and/or human-in-the-loop requirements
• Work closely with other groups including safety, reliability, quality, and logistics to ensure analysis, trades, specifications and design balance customer objectives and requirements
• Communicate with company leadership and customers on the integration of Human Factors Engineering into the design
• Contribute to and facilitate Human Factors Engineering development processes and continuous improvement using best practices by NASA standards and requirements
• Author, review, and approve required documentation to plan, administer, and execute Human Factors Engineering project activities

Skills on Resume: 

• Crew Task Analysis (Hard Skills)
• Error Analysis (Hard Skills)
• HMI Evaluation (Hard Skills)
• Lighting Simulation (Hard Skills)
• Radiation Analysis (Hard Skills)
• System Design Collaboration (Soft Skills)
• NASA Compliance (Hard Skills)
• Stakeholder Communication (Soft Skills)

Job Summary: 

• Apply knowledge of human factors principles (human performance and limitations, perceptual, cognitive, motor skills, anthropomorphic) and techniques (knowledge acquisition, user-interface design, usability evaluation) to product development
• Organize and direct the work of staff and outside consultants working on human factors tasks to effectively and efficiently support product development efforts within the organization
• Usability testing throughout the product development process, from formative testing of early prototypes through usability validation of final designs
• Develop collaborative working relationships with other functions across the organization
• Work with R&D teams to design and develop user interfaces (hardware, software, labeling, instructions and training) and develop user requirements
• Ensure that the company’s usability engineering processes and methodologies meet and surpass the latest expectations of regulatory agencies
• Provide tangible value for customers and business
• Develop strategies for new product submissions, create submission packages, and respond to questions from regulatory agencies
• Keep abreast of regulations and best practices for medical device human factors (e.g. IEC 62366, AAMI HE75, ISO 14971, and the latest FDA guidance on applying human factors engineering)
• Advice management regarding potential improvements to internal processes and regulatory issues related to human factors engineering
• Organizes and manages work to deliver programs, and leads in the execution of work
• Prioritizes tasks by distinguishing urgent from important tasks and assessing cost/benefit trade-offs
• Plans and executes the department strategy to deliver upon responsibilities
• Gathers information, frames problems, devises/executes plans, tracks progress and adjusts/measures success within the scope of responsibility to improve development efforts

Skills on Resume: 

• Human Factors (Hard Skills)
• Usability Testing (Hard Skills)
• Regulatory Strategy (Hard Skills)
• UI Design (Hard Skills)
• Team Collaboration (Soft Skills)
• Process Improvement (Soft Skills)
• Project Leadership (Soft Skills)
• Standards Knowledge (Hard Skills)

Job Summary: 

• Support the development of HF requirements, design practices, airplane design, HF training materials and HF processes and tools
• Applies an interdisciplinary, collaborative approach to plan, design, develop and verify a basic lifecycle balanced system of systems and system solutions
• Evaluates customer/operational needs to define system performance requirements, integrates technical parameters and assures compatibility of all physical, functional and program interfaces
• Performs analyses to optimize the total system of systems and/or system architecture
• Performs analyses for affordability, safety, reliability, maintainability, testability, human systems integration, survivability, vulnerability, susceptibility, system security, regulatory certification, product assurance and other specialty quality factors into a preferred configuration to ensure mission success.
• Supports the planning, organization, implementation and monitoring of requirements management processes, tools, risk, issues, opportunity management and technology readiness assessment processes
• Provide human systems expertise and support to the design and development of human-system interfaces in an integrated and collaborative fashion, supporting design, development, and preparation of deliverables
• Conduct cognitive task analysis to develop the Master Task List
• Conduct Human-in-the-Loop (HITL) testing
• Developing test plans, coordinating with facilities and project personnel, and collaborating with subject matter experts
• Conducting the data collection and analysis, and delivering presentations to NASA customers throughout the design lifecycle
• Provide human factors consulting services to may include design, prototyping, surveys/interviews, heuristic evaluation, cognitive walkthroughs, and usability testing of human-system interfaces

Skills on Resume: 

• HF Requirements (Hard Skills)
• System Analysis (Hard Skills)
• HITL Testing (Hard Skills)
• Task Analysis (Hard Skills)
• UI Prototyping (Hard Skills)
• Data Presentation (Soft Skills)
• Cross-Team Support (Soft Skills)
• Usability Testing (Hard Skills)

Job Summary: 

• Apply Human Factors Engineering (HFE) techniques and principles at all phases of product/technology development
• Exercise independent judgment in the development of study methodology, data collection efforts, data analysis, conclusions, and design recommendations
• Develop user study criteria and detailed methodology for user interface testing for several concurrent projects
• Lead user-centered research and evaluation for design concept models on a diverse user population utilizing experimental data, anthropometric databases, and scientific publications
• Conduct qualitative and quantitative research methods and analysis of data and provide clear and concise feedback to teams promptly
• Collaborate cross-functionally with design, engineering, clinical, regulatory, product marketing, and product development groups
• Author documentation to support submission to FDA and other regulatory bodies including use specification, use-related risk analysis, formative and summative study protocols, and technical reports
• Maintain an active working knowledge of worldwide human factors publications, standards, and both cognitive and physical heuristics

Skills on Resume: 

• HFE Techniques (Hard Skills)
• Study Design (Hard Skills)
• User Research (Hard Skills)
• Data Analysis (Hard Skills)
• Cross-Functional Work (Soft Skills)
• Regulatory Writing (Hard Skills)
• Design Evaluation (Hard Skills)
• Standards Knowledge (Hard Skills)

Job Summary: 

• Establish the Human Factors Engineering strategy for development programs and ensure it is reflected in the development planning
• Plan, design and manage Human Factors studies, including formative and summative evaluation
• Write and review the study protocol and reports
• Analyze study results, ensure they are transferred into the risk management process and provide development teams with conclusions
• Establish and maintain use-related risk management documentation, such as task analysis, hazard assessment and use-related risk assessments
• Author and review Human Factors-related design control documentation, including user requirements and design input specifications
• Author and review submission documentation related to Human Factors, including briefing books and Human Factors Engineering summary reports
• Manage collaboration with external suppliers
• Define the scope of and manage the execution of external services, such as usability studies
• Create instructions for use and training material
• Represent Human Factors Engineering in Device Teams, Technology Centers and Technical Development Teams
• Apply sound knowledge of the regulatory landscape to ensure standard compliant designs, working to Quality Management Systems, risk management and design control

Skills on Resume: 

• HFE Strategy (Hard Skills)
• Study Management (Hard Skills)
• Risk Documentation (Hard Skills)
• Design Control (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Supplier Coordination (Soft Skills)
• Training Material (Hard Skills)
• Cross-Team Representation (Soft Skills)

Job Summary: 

• Responsible for supporting HFE/UE planning, research, and development of Amgen drug delivery devices using HFE/UE best practices and by current regulations and guidelines within the medical device, combination product and bio-pharmaceutical industries
• Collaborate with internal and external partners and across functions with engineering, design, commercial, quality, and regulatory teams
• Support human factors research driving innovative, intuitive, and useful products
• Support project study design, methodology, data collection, root cause analysis to inform design and apply sound HFE/UE knowledge and experience to research, development, clinical studies, product validation in support of regulatory submissions
• Provide human factors engineering expertise to project teams developing combination product drug delivery devices at Genentech, taking into consideration all characteristics of the user, use environment, intended use, and drug therapy
• Collaborate with multifunctional teams including device engineering, regulatory, clinical, quality, marketing, and project management
• Inform and guide the development of innovative products and ensure that those products are safe and easy to use
• Conduct human factors engineering activities within device development programs including ethnographic research, requirements definition research, use-related risk analysis, formative usability assessments, and design validation studies
• Develop instructions for use and training materials for clinical trials and commercial purposes

Skills on Resume: 

• HFE Planning (Hard Skills)
• User Research (Hard Skills)
• Root Cause Analysis (Hard Skills)
• Regulatory Support (Hard Skills)
• Cross-Functional Work (Soft Skills)
• Risk Analysis (Hard Skills)
• Training Material (Hard Skills)
• Product Usability (Soft Skills)

Job Summary: 

• Investigates and defines usability requirements for new product/feature development and facilitates the translation into new projects through formative testing
• Works with field and medical personnel to define the user experience of these products/features
• Gathers and analyzes use errors and issues for medical devices and translates these into specific system risk mitigations
• Creates detailed usability improvement concepts and leads design teams
• Works across product lines, internal departments, and Company sites to create and manage usability improvement plans and usability standards
• Simulates or tests aspects of new projects to evaluate prototypes and optimizes the user experience
• Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors
• Creates and refines usability-related processes and trains others in their use
• Produce documentation, reports and analysis that adhere to FDA Guidelines for usability, as well as IEC Standards 62366 and 60601-1-6

Skills on Resume: 

• Usability Testing (Hard Skills)
• Risk Mitigation (Hard Skills)
• Prototype Evaluation (Hard Skills)
• UX Design (Hard Skills)
• Cross-Functional Collaboration (Soft Skills)
• Process Development (Soft Skills)
• Regulatory Documentation (Hard Skills)
• Team Training (Soft Skills)