• Prepare study materials for usability tests
• Conduct formative and summative usability tests for medical devices and mobile device applications
• Analyze data and compile results and findings for multidisciplinary teams of engineers, developers, clinicians, and executives
• Contribute to HFE documentation for creating the Usability Engineering File for FDA and notifying body submissions
• Conduct Task Analyses, Usability Audits, Cognitive Walk-throughs, and other formative design and evaluation methods
• Make design recommendations based on usability standards and best practices
• Participate in cross-functional design reviews
• Provides human factors engineering expertise to project teams developing combination product drug delivery devices, taking into consideration all aspects of the user, the intended use, the use environment, and the drug therapy being delivered
• Collaborates with multi-functional teams, including Device Engineering, Regulatory, Clinical, Quality, Marketing, and Program Management, to inform and guide the development of innovative products and ensure that those products are safe and easy to use
• Conducts human factors engineering activities within device development programs, including ethnographic research, requirements definition research, use-related risk analysis, formative usability assessments, and final summative design validation studies
• Develops instructions for use and training materials for clinical trials and commercial purposes

Skills: Usability Testing, Task Analysis, Data Analysis, Design Recommendations, HFE Documentation, Risk Analysis, Cross-Functional Collaboration, Instruction Development

• Plan, perform and coordinate the HFI work in a program/project
• Ensure that a human-centered design process and methodology is applied, taking into account usability, usefulness, ergonomics and user work environment
• Be the point of contact with internal and external customers and sub-suppliers for HFI-related issues
• Act as a team member to ensure that the human factors requirements are met and validated in the design work and that the necessary documentation is produced
• Educate colleagues within HFI and user-centered design
• Perform and support research relating to identifying the user, their needs, environments, values, and pain points for the creation of a use specification
• Perform risk analysis according to Human Factors Engineering standards and guidelines (uFMEA, task analysis/ use-error analysis)
• Support the planning, conduct, and reporting of research activities including field studies, heuristic evaluations, user testing, focus groups, surveys, anthropometric analysis etc.
• Perform qualitative and quantitative data analysis
• Write and present compelling findings and recommendations based on research
• Track usability issues throughout the entire product development process and report progress toward meeting usability goals to management

Skills: Usability Research, Risk Analysis, Task Analysis, HFE Documentation, User Testing, Data Analysis, Design Validation, Stakeholder Communication

• Define the Human Factors project scope and timelines in partnership with project management
• Create a support strategy with project management
• Mentor junior Human Factors engineers within the business unit
• Provide HF leadership in the business unit, mentoring and guiding junior engineers to meet their objectives and deliverables
• Apply knowledge of HF principles and timelines to develop support strategies for projects in the business unit
• Provide Human Factors support across the product lifecycle
• Identify customer and user needs
• Develop user and workplace profiles and usage scenarios
• Task analysis, requirements specification, generation of hardware and software design concepts (creation of physical models and prototypes, graphical user interfaces, and product graphics)
• Design user interface, usability testing, user error analysis, and post-launch outcomes analysis
• Responsible for human factors activities across Medtronic’s product range including identifying, planning, monitoring, and executing tasks for the entire project
• Translate requirements into interaction/interface design solution concepts
• Work closely with marketing, product planning, engineering, manufacturing, and regulatory to produce customer-focused designs that not only meet user needs but also factor in business priorities and platform, architecture, and manufacturing constraints
• Develop (physical and interaction) design solutions to complex, system-wide usability problems that require ingenuity and creativity
• Develop physical mock-ups and interactive prototypes of design concepts

Skills: Project Planning, HF Leadership, User Research, Task Analysis, UI Design, Prototyping, Requirements Specification, Usability Testing

• Plan and conduct end-user evaluations of product concepts, analyze data, document evaluation methods and results
• Present design recommendations to the product team
• Use appropriate Human Factors techniques to work with end users to determine end user behavior, preferences, and usage models and integrate these into design concepts
• Prepare clear and effective oral and written reports of the current status, progress and status of the project, as required by project or department management
• Interact professionally at all levels throughout the company and with consultants and customers
• Comply with applicable Corporate and departmental policies
• Maintain technical knowledge current with advancing technology related to Diabetes products and associated accessories
• Complete required training and certifications
• Applies human performance principles, methodologies, and technologies to the design of human-machine systems and products
• Develops and implements research methodologies and statistical analysis plans to test and evaluate developmental prototypes used in all phases of product development and processes
• Designs and executes tests to simulate product use for concept selection/refinement, requirements development, use-related risk identification and formal usability validation with intended users
• Interfaces with design engineers to establish system design, operating, and training requirements and to ensure optimized human-machine interfaces
• Define the Human Factors project scope and timelines in partnership with project management
• Identifies and analyzes technological problems or risks, performs theoretical human factors investigations, and develops and implements research and analysis plans

Skills: User Evaluation, Data Analysis, Design Recommendations, HF Techniques, Report Preparation, Human Performance, Statistical Planning, Interface Design

• Collect and synthesize detailed information on how users interact with Intuitive products through various techniques, including interviews, simulations, direct observations, task analyses, and persona development
• Present results of field observations, research, and usability testing to the New Product Development organization
• Contribute to user interface designs by negotiating design recommendations to mitigate user errors and improve usability
• Assist creation and revision of user-interface requirements documents
• Analyze complaints from on-market products and update the usability risk assessment and escalate usability-related issues
• Design, execute, and report on usability (human factors) tests at various stages of product development from early prototypes through formal FDA-mandated validation testing
• Write and execute usability test protocols
• Analyze test data and write test reports
• Develop validation strategies for projects involving updates to existing products
• Lead the efforts required to create and update usability risk analyses for Intuitive Surgical products
• Maintain traces between use risks, mitigations, and validation test cases
• Reinforce a human-centered design approach across the organization
• Represent the Human Factors function on core teams for large projects
• Coordinate human factors efforts across projects involving several sub-systems
• Manage usability engineering activities within development projects and provide schedules and status to technical product managers and engineering project managers
• Mentor junior human factors engineers (e.g., interns) and others in the organization in usability engineering methods and best practices, as well as Intuitive product development processes
• Lead or support the development of usability engineering processes within the multiport engineering group, including the creation and maintenance of department operating procedures, test plan templates, etc.
• Prepare and review documentation for submission to regulatory agencies and notified bodies
• Answer questions and provide additional justification and rationale for any questions received
• Keep abreast of regulations and best practices for medical device human factors (e.g., IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability Engineering to Medical Devices)
• Advise management regarding potential improvements to internal processes and regulatory issues related to usability engineering

Skills: User Research, Task Analysis, UI Design, Risk Assessment, Usability Testing, Data Reporting, Validation Strategy, Regulatory Compliance

• Conceptualize and execute human factors engineering direction by the client's and development team's goals 
• Producing customer-focused designs that address user needs, platforms, architecture, and manufacturing constraints
• Perform human factors engineering functions for computer-human interface analysis, situational awareness, human-in-the-loop scenarios, ergonomics, and kinematics 
• Perform anthropometric, biomechanical, ergonomic, and systems safety analyses for product development programs and proposals 
• Plan and conduct end-user evaluations of product concepts, data analysis, document evaluation methods/results and present design recommendations to the project team 
• Develop and conduct human factors research studies independently or in conjunction with clients and/or government agencies (FDA, etc.)
• Review existing system designs, workflows, and technology implementation of existing systems, identifying areas for improvement
• Create User Personas, User Flows for use in analysis
• Apply quantitative and qualitative HFE techniques, including heuristic evaluations
• Using the results from the analysis findings, employ state-of-the-art graphical user interface programming techniques, designs, frameworks, and artistic elements to define, implement, test, and evaluate advanced, content-rich, well-integrated, visually appealing user interface components
• Work with a technical team to implement new designs and technologies
• Conduct usability analyses and build relationships with users, integrating their input into the design, testing, and evaluation of human-system user interfaces for the websites

Skills: User Research, UI Design, Task Analysis, Usability Testing, Data Analysis, Heuristic Evaluation, Persona Development, Ergonomic Analysis

• Responsible for understanding the interactions between humans and other elements of a system 
• Applies theory, principles, data, and methods within the engineering design process to assure proper interaction between products, systems, and processes and the people who use them
• Taking into account the user's capabilities and limitations, seeking to ensure that tasks, functions, information and the environment suit each user
• Developing conceptual knowledge of a professional discipline
• Support roles with specialized expertise or technical knowledge in a broad area
• Applies general knowledge of business developed through education
• Understands how the work of their team contributes to the area
• Resolves issues using established procedures
• Consults supervisor or more senior team members for issues outside of defined instructions/parameters
• Collaborates with others to solve issues
• Develops strong customer relationships and serves as the interface between the customer and GE
• Exchanges technical information, asks questions and checks for understanding

Skills: Human Interaction, System Analysis, User Capabilities, Concept Development, Technical Knowledge, Issue Resolution, Customer Relationship, Team Collaboration

• Writing and updating the Clinical Development Plan (CDP)
• Contributing to task analysis, using FMEA, IFU building and validation
• Contributing to developing the evaluation of BD products (methods and capabilities) to assess end-users' acceptance, preference and willingness to adopt the medical device
• Building a study design based on validated CDP
• Establishing an appropriate budget and timeline for the study with input from the corresponding project core team
• Working with his/her line manager to ensure support from C&HF expert team members to get support for various elements of the study, and with other peers, e.g., Statistician, to design the study
• Ensuring appropriate selection, evaluation of proposals, and once the supplier is chosen, training of the study supplier, acquiring signed supplier documents (contract) within study timelines, up to the approval of final payments
• Establishing investigational product specifications for HF studies in collaboration with R&D and the Laboratory (externally or internally)
• Supervising the preparation of the corresponding products on time and in compliance with the defined budget
• Maintaining study documentation
• Completing the final study report and closing of the study file, contributing to publication writing

Skills: Clinical Planning, Task Analysis, Study Design, FMEA Application, Budget Management, Supplier Coordination, Documentation Maintenance, Report Writing

• Designs and evaluates human work systems using human factors principles and techniques to ensure the effectiveness of process safety administrative controls, as well as improve user experience
• Collect and analyze information about how workers perform tasks and interact with systems
• Applies human factors strategies to identify and reduce the opportunity for error
• Enhances the quality of work by improving safety, efficiency, productivity, and user experience using human factors concepts, methods, and principles
• Analyzes work systems to identify process development and improvement opportunities
• Applies human factors approaches in the identification and reduction of potential threats (e.g., those that contribute to human error, such as nuisance alarms)
• Participates in the investigation of adverse events and near misses and incorporates human factors concepts into root cause analyses
• Prepares clear, concise reports and presentations that summarize results and participates in the planning and scheduling of deliverables with direct accountability
• Works both individually and as part of interdisciplinary teams by providing human factors insights, strategies, and methods
• Coaches and demonstrates HF principles and methods to other staff through instruction or applied projects
• Innovate and nurture new HFE competencies into the organization
• Support capital project PHA reviews, especially as related to human factor controls
• Be a member of the process safety core team
• Developing and deploying effective and efficient process safety programs, empowering users to succeed
• Developing measurements and metrics that meet the needs of customers and stakeholders

Skills: System Evaluation, Error Reduction, Task Analysis, Root Cause, Process Improvement, Report Writing, Team Support, Safety Programs

• Work within the Maritime Lifecycle Readiness Division to provide on-site support to the USCG
• Join an established team with even more opportunity to grow
• Maintain secret clearance
• Receive a robust benefits package that includes an Employee Stock Ownership Plan! (ESOP)
• Be a part of an empowered accountability culture where each employee-owner has a meaningful stake in the future success and growth of the company
• Plans all phases of laboratory and field studies to satisfy customer needs
• Conducts evaluations from inception to completion, including the identification of facilities, measurement methods, subjects, collection and analysis of data, and documentation of results
• Accurately documents the results of these evaluations in well-crafted reports, Coast Guard letters, memos, briefings, or demonstrations aimed at increased operational effectiveness
• Recommending design alternatives and trade-offs, or suggesting additional study efforts

Skills: Field Research, Study Planning, Data Analysis, Report Writing, Design Evaluation, User Testing, Clearance Maintenance, Team Collaboration

• Support patient-first corporate strategy by applying knowledge of human factors engineering requirements and best practices to minimize use-related risk and achieve device and system clinical success
• Apply knowledge of device users and use environments and engineering knowledge to the design and development of new products and product changes
• Engage and influence business unit and project team leadership to support human factors and usability engineering activities throughout the product development process
• Partner with clinical, quality, regulatory, marketing, and R&D functions from multiple project teams to promote and execute best practices in human factors and usability engineering
• Identify and mitigate use-related risks, and ensure compliance with internal requirements and external regulations and expectations
• Support planning and executing usability research and evaluations
• Initiate and perform analytical usability assessments of devices and systems
• Document results of usability evaluations and other usability engineering process deliverables, including usability engineering plans, protocols, reports, team debriefs, design reviews, etc.
• Identify opportunities to improve product usability by engaging with clinicians and other device users to collect user feedback (both objective and subjective) on devices
• Provide creative solutions to alleviate complex usability problems
• Maintain current knowledge of human factors and usability regulations, expectations, and best practices

Skills: Usability Testing, Risk Analysis, Product Design, User Research, Compliance Support, Team Coordination, Feedback Gathering, Problem Solving

• Designs, reviews and tests user interface designs for avionics products and aviation web / mobile services
• Ensures consistency using Garmin aviation user interface guidelines by leading user interface reviews, providing UI training to software engineers and soliciting feedback to improve guidelines
• Attains in-depth knowledge of product operation including configurations and variations of Garmin integrated flight decks
• Writes system concept, design and description documentation to support the creation of features and products
• Evaluates and tests new products and features during development including concept evaluations, bench testing, flight simulation testing and flight testing and certification
• Supports customer visits and reviews
• Serves in a leadership capacity to design new features including coordination of stakeholder input including flight operations or customer test pilots, technical research and competitive analysis
• Identifies areas of aviation and human factors training needs within the aviation software team and develops and implements training to address the needs
• Leads the development, coordination and execution of human factors evaluations
• Represent the pilot by working with the software development team to ensure ideal solutions are developed and deployed

Skills: UI Design, UI Review, Product Testing, Flight Simulation, Stakeholder Coordination, Pilot Advocacy, Documentation Writing, Training Development

• Assure full compliance with Ergonomic, Harmony, and Stowage requirements (Trustmark, SDS, etc.), working with Design Studio, Design and Release, and Vehicle Engineering activities
• Participate in user research and conduct clinics to assess the usability of various HMI proposals
• Validate user interface designs of Ford and Lincoln vehicles to ensure they are usable, intuitive and support the key "Moments That Matter" experiences for the customer
• Participate in research and synthesize findings into actionable insights
• Modeling information structures, screen layouts, screen flows and other UI attributes
• Utilize production intent prototypes to evaluate instrument cluster, steering wheel, center stack infotainment systems, and other mobility-related customer touch points
• Assist in developing program targets, assumptions and new vehicle features by identifying customer needs and wants through the use of detailed benchmarking and the application of ergonomic, harmony and stowage standards and principles
• Drive solutions to raised ergonomic concerns by leading cross-functional teams while ensuring designs are compatible with customer wants, attribute targets, corporate requirements, service, assembly, etc.
• Utilize Ford corporate tools in the application and assessment of ergonomic standards for vehicle components and drive the compliance or deviation process
• Provide input to, and sign off on, graphics for controls and displays
• Participate in appropriate meetings to support the program(s), including upper and senior-level management reviews
• Routinely present ergonomic issues to Program Management/Chiefs

Skills: Ergonomic Compliance, HMI Evaluation, UI Validation, User Research, UI Modeling, Prototype Testing, Benchmark Analysis, Cross-Functional Leadership

• Guide and inform product designs, optimizing for human factors and ergonomics (HFE)
• Serve as a user advocate across the product development process
• Design and conduct a range of HFE assessment and research methods, applicable to all product phases from concept to validation
• Organize and manage HFE studies in internal laboratory settings as well as in field studies with the Military and DoD Civilian personnel
• Establish best practices in design that maximize user experience and comfort
• Augment existing HFE core competencies or grow new competencies into the COE
• Developing human factors (HF) engineering strategies and leading HF activities on drug-device combination product program teams, including ethnography, requirements definition research, use-related risk analysis, formative usability studies, and summative usability studies
• 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 user inquiries, user studies, data gathering, and data analysis
• Collaborate with the internal cross-functional design team and external vendors
• Work with other HF team members to develop and implement HF process improvements

Skills: HFE Strategy, User Advocacy, Risk Analysis, Task Analysis, Study Management, Data Analysis, UI Evaluation, Cross-Functional Collaboration

• Leads human factors engineering work and research
• Provide experience and familiarization with the engineering staff, methods, techniques, theories, standard operating procedures, policies and projects
• Designing and executing tests to simulate product use for verifying and validating product performance, reliability, and usability
• Actively participate in device program teams to ensure sound human factors principles are considered and implemented
• Create and communicate project plans, tasks and deliverables and manage time to meet project deadlines
• Reporting pertinent information at key milestones through clear, concise oral and written communications
• Develop product prototypes to explore and validate user interfaces and a demonstration prototype
• Participate in efforts to develop processes and procedures that align with company initiatives and relevant human factors standards
• Provide technical supervision to less-experienced human factors engineers
• Reviewing deliverables and ensuring they meet standards
• Delivering test results, conclusions, and opportunities for improvement
• Conducting usability testing, field research, and interviews
• Mentoring and supporting jr human factor specialist
• Researching and maintaining current knowledge of medical industry regulations

Skills: HFE Leadership, Usability Testing, Prototype Development, Project Planning, Process Development, Team Mentorship, Field Research, Regulatory Knowledge

• Developing human factors engineering strategies and leading HF activities on drug-device combination product program teams
• Writing and reviewing HF sections for health authority submissions
• Interacting with health authorities during face-to-face meetings and in written responses
• Interacting with senior leaders about HF strategy and implementation
• Improving internal Human Factors processes at MedImmune to ensure consistency, compliance and efficiency
• Provide expert advice on human factors within the project across rail engineering, safety and system assurance disciplines
• Ensure effective identification of human factors risks/issues and pragmatic implementation of human factors design solutions within a project to the satisfaction of the client and regulatory requirements
• Responsible for performing detailed concept of operations analysis and requirements allocation to translate customer requirements into software specifications for the Aegis Display System within the Human Systems Engineering department
• Work collaboratively with a multi-disciplinary team, including system architects, systems engineers, and customer representatives, to provide early design guidance to enhance system usability
• Develop user interfaces, prototypes, and mockups based on interaction/task analysis and industry best practices
• Complete systems engineering-related tasks to meet cost and schedule
• Responsibilities will also include interfacing with the customer to solicit design feedback via reviews and performing test and evaluation activities
• Interfacing with internal software teams to isolate and fix issues as they arise for various functional areas
• Supporting the various testing events

Skills: HF Strategy, Submission Writing, Regulatory Interaction, Process Improvement, Risk Identification, UI Development, Task Analysis, Team Collaboration

• Contribute during all phases of the product development cycle with particular emphasis on Human Factors Engineering and Usability Assessment
• Direct and/or collaborate on user needs/requirements gathering activities including ethnographic research, use case analysis, and/or task analysis
• Plan, moderate, and manage Formative usability studies during concept development as well as Summative usability studies for human factors validation
• Write clear testing protocols, set up testing environments, manage recruitment of study participants, schedule research sites, moderate usability sessions, analyze testing results, identify design improvement opportunities, and author summary reports that adhere to industry standards
• Support analytical use of risk analysis to predict and/or assess use error risk potential and identify design mitigations
• Assist with conformance to Design Control and FDA guidance to ensure product quality through human factors-focused technical reviews
• Translate research results into objective and actionable design direction
• Encourage collaboration between the product development team and other related disciplines (ie, regulatory, clinical, marketing, quality, manufacturing, and other functions) regarding potential use error issues as they may relate to user/patient safety
• Support the development and refinement of standard operating procedures related to Human Factors Engineering, with close connection to the Product Development Process and Quality Management System
• Develop close working relationships with new and existing customers

Skills: Usability Assessment, User Research, Task Analysis, Study Management, Risk Analysis, Design Control, Design Recommendations, Cross-Functional Collaboration

• Provide innovative and creative solutions to provide a state-of-the-art user experience for unmanned products
• Leads groups designing interfaces for unmanned systems, crew stations, mission personnel workstations, and maintenance control stations
• Creates, evaluates and modifies prototypes to support evolving hardware and software application development
• Develop user profiles, with emphasis on human error control, display issues, visual interaction, physical manipulation and task and objective analyses
• Develops and applies software design/usability processes in the investigation of technical problems
• Provides product usability, evaluation and support to product development teams, including the analysis and investigation of applications/systems including tactile methods, visual graphics, web, multimedia, voice response and conversational user interaction
• Assist in developing design concept and implementation, providing input on user design considerations
• Produce specifications describing user requirements and internal structures for the product in development
• Design, execute, and report on usability (human factors) research at various stages of product development, from early prototypes to validation testing by the FDA
• Moderate usability research sessions with confidence and poise to gather key insights on potential use events that occur
• Translate uFMEA, risk/hazard analysis, and/or IFU into an appropriate usability testing protocol
• Assist in defining user needs, translation of needs into measurable specifications, and the heuristic review of device-user interfaces
• Write and execute generative and evaluative research protocols, analyze research insights and data, and write test reports
• Provide input on FDA and Global usability regulatory standards (IEC 62366-1:2015, ANSI/AAMI HE75, EU MDR)
• Build human factors and usability research proposals and budgets
• Work with the Human Factors and Usability Manager and Director of User Research on improving departmental processes around human factors and usability research

Skills: User Experience, Interface Design, Prototype Evaluation, Task Analysis, Usability Research, Risk Analysis, Regulatory Support, Research Reporting

• Author, review, and edit Human Factors engineering documentation related to assigned projects
• Research protocols, research reports, Human Factors plans, and other design control documentation
• Create and conduct formative and summative studies to support medical device design optimization and identify potential use errors
• Work cross-functionally with the core team to ensure user interface requirements are met, and risk controls about patient use have been applied and are effective
• Ensure Insulet’s Human Factors Engineering process complies with FDA recognized guidance and standards including 62366, HE-75, and others
• Analyze results from formative evaluations and make recommendations for improvements based on Human Factors guidelines and best practices
• Provide research and design inputs related to human capabilities and product interactions to inform design and contribute to the verification and validation of medical devices
• Participate in the development of product requirements and evaluation of risks related to product use (risk analysis)
• Provide technical advice and support to program planning activities to achieve near-term program milestones, including Initial Investment Decision (IID) and Final Investment Decision (FID)
• Assist in the launch of program system developments in fulfillment of the program’s baseline following FID
• Responsibilities include Human Factors Engineering tasks, assessments, analyses, acquisition documentation support, HF requirements and specifications, SIR input, vendor HF oversight, CHI/GUI development, HF testing strategies, and Integrated Human Factors Plan

Skills: HF Documentation, Study Execution, Risk Analysis, Cross-Functional Work, Regulatory Compliance, Design Recommendations, Product Requirements, HF Testing Strategies

• Subject matter expert in human factors and usability engineering
• Works with an in-house team and external partners to develop product designs for point-of-care IVD systems
• Leads the team to conduct formative and summative studies of designs with customers to understand the user experience
• Defines experimental strategy, drafts protocols, collects and evaluates data, writes reports, and determines design direction based on data
• Interfaces with a cross-functional project team to ensure design requirements are met and the product meets quality standards
• Maintains detailed documentation throughout all phases of research and development and assists in transfer to manufacturing
• Coordinates activities with outside suppliers and consultants to ensure the delivery of supplies or services to meet scheduled timelines
• Identifies and communicates with key contacts outside their area of expertise
• Work on the implementation of human factors/ usability engineering in projects and ensure compliance with the given regulations for medical devices and combination products
• Plan and perform Human Factors Engineering (HFE) with a focus on design validation
• Support the continuous improvement process of the BI quality system for combination products, especially related to usability and design validation
• Facilitate a sound exchange with the device design and development team, in particular with risk management, design engineering, medical and marketing
• Lead employees in the field of design validation activities and support the combination product projects in compiling submission-relevant documentation

Skills: Usability Expertise, Study Leadership, Data Analysis, Cross-Functional Coordination, Regulatory Compliance, Documentation Management, Supplier Coordination, Design Validation

• Proven track record performing the above Duties and Responsibilities
• Understanding of Human Factors Usability Engineering process
• Proven successful FDA submissions with a factor component
• Experience with Human Factors FDA Guidance, and IEC 62366, and management of HF usability file for a medical device
• Ability to read and interpret documents of advanced technical complexity
• Ability to write reports and research findings of a technical nature
• Ability to speak and present effectively one-on-one as well as in small and large groups of professionals including customers, clients and collaborators, both inside and outside the organization
• Must have basic mathematical skills, including the understanding and ability to apply basic statistical and arithmetic principles, work with tabular data, and create and interpret graphs 
• Must have the ability to solve complex problems and weigh possible solutions to determine ranked options to deliver optimal outcomes
• Ability to assess problems involving several variables in changing situations
• Must be proficient in the Microsoft Office Suite

Qualifications: BA in Cognitive Science with 4 years of Experience

• Demonstrable understanding and experience of the application of Human Factors Integration and Human Factors Engineering
• Good understanding of Systems Engineering and disciplines that interact with Human Factors (Supportability, Training, Safety, Equipment)
• Experience working with commercial and/or government clients
• Experience in Human Factors / Usability Engineering
• Experience with medical device products
• Strong understanding of medical device product design and regulatory processes
• Excellent organizational, technical problem-solving and interpersonal skills (written and verbal)
• Experience with medical device design and development processes that conform to standards including IEC 62366, ISO 14971, IEC 60601 and HE 75
• Experience in structuring, recruiting, conducting, and reporting on formative and summative usability evaluations, especially involving medical devices

Qualifications: BS in Mechanical Engineering with 3 years of Experience

• Industry experience coordinating and conducting Usability Testing, including measurement of user performance, data analysis and reporting of results
• Experience in mobile application software design
• Must have fluency with web and mobile standards and technologies
• Strong interpersonal skills and the ability to collaborate actively and proactively with others in a cross-functional team
• Self-motivated and self-managed with a high degree of analytical ability and intellectual curiosity
• Familiarity with human factors processes and guidelines towards the development of medical devices (e.g., FDA guidance, IEC 62366, AAMI HE75)
• Passionate about applying OMI experience and analytical skills in an innovative and collaborative environment
• Strong interpersonal skills and are skilled at developing relationships across organizational teams
• Excellent oral and written communication skills
• Proficient at multi-tasking, prioritizing assignments, communicating progress and meeting deadlines
• Able to obtain an Interim Secret security clearance by start date and can ultimately obtain a Top Secret level clearance
• Possess an MS degree in Engineering or equivalent
• Experience in submarine combat systems test and evaluation
• Previous experience with the evaluation of Navy combat systems OMI

Qualifications: BS in Industrial Engineering with 7 years of Experience

• Experience evaluating and documenting HF within design-controlled processes in the medical device or other highly regulated domains
• Experience working cross-functionally on risk management activities
• Working knowledge of relevant human factors, design controls, and risk management regulations, standards, and guidance for medical devices and combination products
• Fully versed in FDA’s Guidance for Applying Human Factors and Usability Engineering to Medical Devices, HE75, and IEC 62366-1, -2
• Ability to communicate effectively with verbal and presentation skills as well as excellent writing skills
• Strong interpersonal skills and the ability to collaborate actively and proactively with others in a cross-functional team
• Experience managing 3rd party vendors
• Experience in combination product development engineering in a pharmaceutical, medical device, regulated environment or related field
• Experience representing the human factors body of work to regulatory agencies and during audits
• Experience working in matrix-managed teams and participating in more than one project at a time
• Experience applying Human Factors / Usability Engineering, including design and execution of formative and summative studies, to the design and development of medical devices or consumer products
• Working knowledge and experience with applicable HF regulations and with ISO, FDA, International regulations, and ASTM standards
• Effective communicator in team environments with strong interpersonal skills and can interface effectively with research, operations, and external suppliers and manufacturers
• Proficiency utilizing the MS Office Suite (Word, Excel, PowerPoint etc.) 

Qualifications: BA in Psychology with 8 years of Experience

• Strong experience in Human-centered design methodologies
• Experienced in leading the execution of simulated testing from early patient handling studies through to Design Validation / Summative Human Factors studies
• Extensive experience in the integration of Risk Management considerations and User Requirements into iterative, patient-centered Device Design
• Proficient in Adobe Illustrator graphics tool
• Excellent verbal and written communication skills including technical reports and regulatory dossier preparation
• Strong interpersonal and communication skills in written and verbal form
• Strong qualitative and quantitative research skills
• Experience in appropriately scoping projects for high-growth startups
• Experience introducing new products to market and/or affecting field operations

Qualifications: BS in Systems Engineering with 5 years of Experience

• Proven experience as a Human Factors Engineer (HFE) or similar role
• Experience in creating study protocols, recruiting study participants and performing usability studies
• Experience conducting statistical and qualitative data analysis
• Good knowledge of worldwide human factors publications, standards, and both cognitive and physical heuristics (IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability Engineering to Medical Devices)
• Prior experience managing a usability test lab or other research facility
• Demonstrable experience with HFE, UI/UX techniques applied to websites, web-based applications
• Deep knowledge of current website development technologies and techniques including CSS, HTML, scripting languages/tools
• Experience with Axure, Sketch, Adobe XD or other multi-platform design and prototyping tools
• Experience with User-Centered Design techniques
• Superior client skills, ability to work across all organizational levels
• Experience with Agile methods
• Experience with Section 508/W3C accessibility design and testing

Qualifications: BS in Electrical Engineering with 6 years of Experience

• Demonstrated experience leading human factors/usability in new product development
• Strong interpersonal skills with the ability to communicate with all levels of management with diplomacy and tact
• Ability to work independently with minimal supervision
• Ability to address issues and solutions in clear and concise written and verbal communication
• Comprehensive knowledge of Human Factors Engineering
• Prior experience developing regulated medical devices, including performing human factors analyses and designing and executing formative and summative human factors usability studies
• Familiarity with relevant quality regulations (21 CFR Part 820.30), human factors/usability engineering standards (IEC 62366-1, ANSI HE75, ISO 14971), and FDA guidance
• Proven track record of interdisciplinary collaboration with R&D, Quality, Regulatory, Marketing and other functions

Qualifications: BS in Software Engineering with 3 years of Experience

• Able to perform task analysis and use error assessments to identify critical tasks
• Able to generate Human Factors and Design Validation objectives and deliverables plan
• Must be able to work in a fast-paced environment
• Experience conducting usability studies and hazard analysis of use-related hazards,
• Experience with industry standards regarding medical device human factors and usability (FDA, HE 75, ISO 62366) in the medical device development process
• Experience with medical device requirements (Class I-II), design controls, risk assessments, and the 510k process
• Experience with focus groups, voice of the customer, and human factor formative and summative studies
• Excellent skills in English and German, verbal and written
• Solid experience in applying Human Factors Engineering to medical device development from concept generation to health authority submission

Qualifications: BS in Ergonomics with 4 years of Experience

• Excellent communication, presentation and customer interface skills
• Ability to manage and prioritize multiple projects
• Solid math and science background
• Computer experience with Microsoft Office products, Internet browsers, and Outlook
• Must have the ability to obtain and maintain a security clearance
• Must be able to quickly evacuate buildings in the event of an emergency
• Must be able to accurately communicate ideas in writing and verbal communication
• Able to maintain a positive work atmosphere by behaving and communicating in a manner that fosters good relations with customers, clients, co-workers, and management

Qualifications: BA in Behavioral Science with 2 years of Experience

• Experience with User Centered Design methods including heuristic evaluation and usability testing
• Ability to analyze existing systems and propose user experience enhancements
• Ability to conduct user interviews and observations and elicit requirements
• Good knowledge of industry best practices
• Strong interpersonal, verbal, and written communication skills
• Experience working in cross-functional, geographically dispersed teams 
• Ability to influence and promote HFE to stakeholders
• Good knowledge of task analysis methods and/or business process modeling methods
• Experience with advanced collaboration tools and technologies

Qualifications: BS in Information Technology with 4 years of Experience

• Experience in Human Factors Engineering
• Experience with the medical device industry developing Class II or Class III medical devices
• Ability to analyze data and write up reports
• Experience in medical device software or capital equipment systems
• Experience with Unity development
• Experience with C++/C# development
• Experience in programming for User Interfaces (Qt, or similar)
• Hands-on experiences with HMIs for autonomous vehicles or automotive/aerospace applications

Qualifications: BS in Mechanical Engineering with 3 years of Experience

• Experience developing, administering and analyzing Human Factors questionnaires such as Usability, Workload, and Situational Awareness
• Experience developing and executing test procedures and writing a final verification report
• Proficiency in delivering technical solutions/contributions to the completion of project milestones under general supervision
• Must have an active DoD Secret (or higher) clearance (with a background investigation within the past 6 years or enrolled into Continuous Evaluation)
• Must have the ability to obtain and maintain Special Access Program (SAP) clearance
• Proficiency in writing and executing demonstration and test procedures
• Experience conducting structured anthropometric evaluations and design including lighting, and acoustics
• Ability to clearly and accurately express engineering findings orally and in written technical reports and presentations
• Familiar with the interpretation and application of systems safety, personnel survivability, and habitability requirements to system design
• Experience with CAD Tools NX and NX Jack Expertise
• Experience with system engineering processes and tools (DOORS)
• Experience with MATLAB or SIMULINK
• Experience preparing Human Systems Interface Style Guides
• Understand systems and design thinking, as well as HMI/HCI design principles and practices

Qualifications: BS in Computer Engineering with 6 years of Experience

• Experience with medical devices in renal replacement therapy / extracorporeal therapies
• Profound knowledge in usability engineering management and the medical device industry related to regulatory and normative standards
• Basic knowledge of workflow and Process analysis
• Good knowledge of Project Management methodologies, tools and best practices
• Strong commitment and flexible organization of working time and environment
• Ability to work independently using a quality and result-oriented approach
• Proven organizational and planning skills
• Ability to work independently as well as in a team environment
• Demonstrates initiative, results-oriented, strong sense of urgency
• Strong analytical, planning, organization and time management skills
• Effective decision-making skills and the ability to negotiate and balance decisions and priorities across the needs of several functional departments and willingness to make tough decisions
• Excellent social skills and competencies in cooperation, conflict management and team skills
• Excellent communication and negotiating skills
• Able to build cross-functional relationships

Qualifications: BS in Human Factors Engineering with 5 years of Experience

• Demonstrated ability to work within a team environment with minimal supervision
• Strong communication, organization, and prioritization skills
• Must be able to meet the Anthropometric Size Requirements for confined space
• Proficiency with Human 3-D Modeling Software (JACK, RAMSIS, Santos, etc.)
• Familiarity with Human System Integration philosophy
• Professional certification in Human Factors / Ergonomics (i.e., CCCPE, BCPE)
• Experience in Human Factors/Ergonomics and System Safety in product design
• Familiarity with User-Centered Design philosophy and approaches
• Experience with safety and HFE-related Military Standards (i.e., MIL-STD-882, MIL-HDBK-764, MIL-STD-1472)
• Able to construct and update Fault Tree Analysis (FTA) and Event Tree Analyses (ETA)
• Good understanding of Functional Failure Analysis

Qualifications: BA in Cognitive Science with 4 years of Experience

• Good understanding and specific knowledge on applying Human Factors Engineering processes to medical device development from concept generation to health authority submission
• Experience in project/program management
• Experience in developing apps, software and/or industrial design
• Experience in managing user studies (performed by vendors or self-managed)
• Experience in developing and documenting Human Factors activities for medical devices as required by regulation
• Good understanding of the risk management activities
• Broad experience with application of design theories, methods, principles, and concepts to a portfolio of multiple information technology and consumer products and services designs
• Ability to work both independently and collaboratively across diverse technologies in a dynamic, hands-on, and creative environment 
• Excellent analytical and problem-solving skills
• Excellent verbal and written communication skills

Qualifications: BS in Software Engineering with 3 years of Experience

• Demonstrated ability to plan, conduct, analyze, and deliver written reports of the results from usability testing
• Experience producing observational findings from usability testing, leading to the identification of usability issues and risks
• Able to communicate effectively with a wide range of stakeholders
• Detail-oriented and able to work independently on a variety of tasks
• Experience applying Human Factors principles and practices to medical device design and regulation
• Experience planning, conducting, analyzing, and delivering detailed written reports of formative and summative user experience evaluations
• Excellent collaboration and organization skills
• Excellent verbal and written communication skills
• Ability to multitask in a fast-paced environment
• General knowledge of user interface design, human perception, cognition, anthropometry, biomechanics, human behavior, and physiology

Qualifications: BS in Ergonomics with 4 years of Experience

• Proven applied experience with user-centric human factors design best practices
• Background with voice-enabled applications
• Must be comfortable speaking/presenting content
• Strong time management and self-management skills 
• Must be effective in a virtual working environment
• Must have a strong customer focus
• Ability to present oneself professionally at all times
• Good knowledge of VXML, SRGS and SISR standards, lexicon development, GRXML grammar development, usability testing, voice biometrics and/or speech application tuning
• Excellent English oral and written skills

Qualifications: BA in Visual Communication with 3 years of Experience

• Work experience as a Human Factor Engineer in aerospace, automotive, robotic or similar industry
• Experience working in a matrix organization and collaborating with various stakeholders
• Experience in designing and evaluating Human-Machine interface design for cockpit display applications for military or commercial aircrafts
• Knowledgeable in flight deck philosophy and crew alerting philosophy
• Knowledgeable in FAA regulations for Part 23 aircraft
• Strong understanding of the overall aircraft functions to facilitate design discussions for the usability and safety of Human-Machine interface features
• Strong oral and written communication skills
• Experience in IOT wearable-type devices and hardware design
• Experience in creating ergonomic studies, executing tests, performing statistical analysis and visualizing information
• Strong verbal and written communication, demonstrated interpersonal skills, detail-oriented, and understands the importance of design
• Good knowledge of the eyewear industry or head wearable devices

Qualifications: BS in Robotics with 5 years of Experience

• Passionate about user experience and design research, as evidenced by career and education choices
• Familiar with how to plan and conduct research
• Must have experience translating research findings into actionable recommendations
• Familiar with FDA Human Factors standards and guidelines
• Able to be committed to high standards of workmanship and attention to detail
• Comfortable speaking in front of groups of people
• Ability to act with an inclusive mindset and model these behaviors for the organization
• Working knowledge of IEC 62366 and FDA Guidance regarding HFE / Usability process and documentation

Qualifications: BA in Linguistics with 3 years of Experience

• Experience in implementing Human Factors Engineering/usability to medical device development, ideally within a pharmaceutical organisation
• Familiarity with evolving apps, software and/or industrial design
• Experience in the field of usability or human factors engineering with medical devices
• Familiarity with the human factors requirements of ISO 13485 and the FDA’s Quality Systems Regulation
• Must have strong consulting skills, strong presentation skills and experience managing or facilitating change through a consultative role
• Experience with healthcare simulation
• Excellent skills in English, verbal and written
• Experience in applying Human Factors Engineering/usability to medical device development in the pharmaceutical industry
• Good understanding and specific knowledge of applying Human Factors Engineering processes to medical device development from concept generation to submission
• Experience in developing apps, software, and/or industrial design, in managing user studies and in developing and documenting Human Factors activities for medical devices as required by regulation

Qualifications: BS in Aerospace Engineering with 5 years of Experience