Job Summary: 

• Preventative maintenance, testing and calibration of medical devices in the hospital/healthcare environment
• Approve new equipment by conducting tests, ensuring adherence to codes, and making modifications.
• Install, diagnose, repair and calibrate equipment on-site in healthcare facilities
• Prepare biomedical reports by collecting, analyzing, and summarizing information and trends.
• Ensuring safety and taking action to change and improve and promptly support the business where special circumstance arises
• Delivering high levels of customer satisfaction, and maintaining DMR and DHF files.
• Independently design the study, execute, and perform data analysis and reporting. 
• Drafting SOPs and maintaining trackers and involved in calculating line metrics. 
• Work with other staff and provide support to characterize fill-finish unit operations.
• Work with mechanical, electrical, systems, core technology, quality, test, clinical, regulatory and software teams.
• Focus on creating platforms that can be seamlessly integrated into multiple product architectures.

Skills on Resume: 

• Technical Proficiency (Hard Skills)
• Equipment Evaluation (Hard Skills)
• Biomedical Reporting (Hard Skills)
• Safety Management (Soft Skills)
• Customer Satisfaction (Soft Skills)
• Study Design (Hard Skills)
• SOP Development (Hard Skills)
• Collaboration (Soft Skills)

Job Summary: 

• Act as a team lead for Field Service Representatives.
• Responsible for preparing scientific reports and publications. 
• Responsible for leading a team from beginning to end of a project.
• Oversees all Biomedical projects while collaborating with a multidisciplinary team of stakeholders.
• Provide training on more advanced applications of the company’s products to end-users.
• Coordinate the onsite activity with internal resources as well as with customer resources to ensure a smooth execution.
• Follow up regularly with key accounts to ensure the satisfaction of the equipment from a biomedical perspective.
• Work with all stakeholders to improve the outcomes of a project (new installations, customer repairs, or troubleshooting issues).
• Provide support for intellectual property protection, and Health Canada/FDA regulatory submissions.
• Work with the device team and data science team to implement algorithms in production firmware and server backend.

Skills on Resume: 

• Leadership (Soft Skills)
• Scientific Writing (Hard Skills)
• Project Management (Soft Skills)
• Collaboration (Soft Skills)
• Training (Soft Skills)
• Customer Relationship (Soft Skills)
• Regulatory Compliance (Hard Skills)
• Technical Proficiency (Hard Skills)

Job Summary: 

• Handling regulatory and QA assignments with a good understanding of medical process standards ISO13485, ISO14971.
• Preparing regulatory documentation for submission to regulatory authorities
• Developing and coordinating test procedures for characterization, verification and validation testing, bench and usability testing
• Ensure compliance with applicable standards and guidelines.
• Formulating documentation required for V&V, protocols and reports, by using applicable standards.
• Creating and maintaining test plans according to risk analysis matrix and system and SW specifications.
• Creating, validating and maintaining new test methods
• Validating new test jigs and applying proper test method validation techniques.
• Leading and planning the execution of environmental, safety and biocompatibility testing
• Managing 3rd party testing activities, and supporting notified body and FDA audits
• Working closely with other R&D, QA and RA team members.

Skills on Resume: 

• Regulatory Compliance (Hard Skills)
• Documentation Preparation (Hard Skills)
• Test Procedure (Hard Skills)
• Standards Compliance (Hard Skills)
• Documentation Formulation (Hard Skills)
• Test Plan  (Hard Skills)
• Test Method Development (Hard Skills)
• Leadership (Soft Skills)

Job Summary: 

• Develop and implement novel signal processing/analysis algorithms in MATLAB for patient/subject monitoring and aid in diagnosis/therapy based on physiological signals such as body temperature, electrocardiogram (ECG), photoplethysmography (PPG) and electroencephalography (EEG) signals.
• Execute/administer R&D programs, both independently and collaboratively. 
• Interface with funding agencies and program officials.
• Assist in conceiving new ideas within the Company’s mission statement and write grant proposals.
• Assist with the design and implementation of clinical studies to acquire bio/physiological signals from human subjects for algorithm development and validation.
• Develop and validate algorithms based on acquired human subjects/clinical data.
• Perform statistical analysis of acquired and processed data.
• Develop and maintain regulatory documentation for related clinical studies (Trial Master File and Study Site File) as per current Good Clinical Practice (cGCP).
• Participate in training, monitoring and audits of clinical sites, and present at scientific conferences.

Skills on Resume: 

• Signal Processing Algorithm (Hard Skills)
• Research (Hard Skills)
• Grant Writing (Hard Skills)
• Funding Interface (Soft Skills)
• Clinical Study Design (Hard Skills)
• Algorithm Validation (Hard Skills)
• Statistical Analysis (Hard Skills)
• Regulatory Compliance (Hard Skills)

Job Summary: 

• Undertake scheduled PPM Maintenance, Servicing and Modification
• Undertake Emergency Repair and Rectification and respond to emergency call-outs.
• Ensuring best practice in the maintenance, control and observance of engineering processes and procedures for Servicing and Repair
• Ensuring engineering activities are undertaken using appropriate engineering safety precautions and standards
• Manage Spare parts required for the Servicing and Repair
• Ensure high standards of Engineering Hygiene are maintained at all times
• Liaising with the Contracts Manager for Externally Supported Equipment and manufacturers' maintenance contracts
• Maintain accurate documentation associated with the Service and Repair
• Providing the appropriate Clinical Staff with the latest technical advice and assistance
• Control test equipment and inventories, and operate following Company Policy and Procedures

Skills on Resume: 

• Technical Maintenance (Hard Skills)
• Emergency Repair (Hard Skills)
• Engineering Processes (Hard Skills)
• Safety Compliance (Hard Skills)
• Inventory Management (Hard Skills)
• Hygiene Standards (Soft Skills)
• Contract Management (Soft Skills)
• Documentation Management (Hard Skills)

Job Summary: 

• Collect, coordinate information, and create regulatory documentation for submission to regulatory agencies or commercial partners, and clinical research projects.
• Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process.
• Provide clear regulatory guidance and regulatory working template to R&D for testing protocol, report, labeling, and associated standards
• Review advertising and marketing material for appropriateness and compliance with regulatory requirements
• Maintain current knowledge of FDA and international regulations, guidance, and standards applicable to company products
• Evaluate regulatory compliance of document/product/process/test method changes
• Control all equipment publications and manufacturers' technical information, ensuring that all amendments are carried out
• Ensuring that MHRA Device Alerts are read and Serious Equipment Failure signals are actioned
• Understand and operate the following Health, Safety and Hazard Warning Notices applicable
• The compilation of COSHH and Health and Safety risk assessments ensures that regular reviews are carried out
• Comply with all Risk Assessments and carry out personal Risk Analysis of any Hazardous Activity

Skills on Resume: 

• Regulatory Documentation (Hard Skills)
• Representation (Soft Skills)
• Guidance Provision (Soft Skills)
• Marketing Material (Hard Skills)
• Compliance Evaluation (Hard Skills)
• Publication Control (Hard Skills)
• Health and Safety Compliance (Hard Skills)

Job Summary: 

• Takes part in product development throughout the product life cycle.
• Defines the V&V masterplan and executes in-house bench tests
• Supervise the execution of bench tests by 3rd party labs
• Prepare V&V protocols and reports, and help vendor during PM/ service
• Defines and writes testing/manufacturing/inspection work instructions.
• Supports engineering, manufacturing, Regulatory, and QC activities.
• Implement all the technical activities needed to install, repair, and implement recalls of all medical equipment.
• Report all his technical activities to the direct supervisor weekly.
• Follow up all the processes and procedures according to the company's internal policy and procedures.
• Know how to transfer and internal training for newcomers in the service field.
• Report any dilemma that could harm the company to his direct manager

Skills on Resume: 

• V&V Masterplan (Hard Skills)
• Test Supervision (Soft Skills)
• Report Preparation (Hard Skills)
• Work Instruction (Hard Skills)
• Multifaceted Support (Soft Skills)
• Technical Implementation (Hard Skills)
• Communication (Soft Skills)

Job Summary: 

• Work directly with RandD, Design Assurance, Clinical Affairs, Regulatory Affairs and other departments
• Understand product regulations and standards to complete technical documentation
• Author technical documents to support risk assessments
• Author Post Market Surveillance plans and reports, clinical evaluation reports
• Perform a literature review of toxicological information related to chemicals
• Author biological risk assessments for new products
• Support existing product technical file remediation
• Author product risk assessments and ensure risk traceability
• Design requirements and risk mitigations are documented and maintained
• Perform post-market surveillance activities
• Provide support to manufacturing teams in the generation of risk documentation.

Skills on Resume: 

• Collaboration (Soft Skills)
• Regulatory Knowledge (Hard Skills)
• Technical Writing (Hard Skills)
• Risk Assessment (Hard Skills)
• Literature Review (Hard Skills)
• Biological Risk (Hard Skills)
• Remediation Support (Soft Skills)
• Post-Market Surveillance (Hard Skills)

Job Summary: 

• Develop new products through the documented design and development process.
• Design improvements and enhancement to existing products.
• Establish product specifications and create drawings, testing methods and requirements.
• Understand and comply with the Mueller Quality System and current regulatory requirements.
• Coordinate design teams and guide the development and production process 
• Ensure the project meets milestones and deadlines.
• Serve as an engaged member of the Risk Management team. 
• Provide input and feedback regarding risk analysis activities.
• Help the HoD in administrative work, and attend service calls.
• Draft letters to vendors on the system and follow up of BME related matters (via telephone or E-Mail)
• Maintain logbooks, and do preventive maintenance of all equipment that is not under AMC & CMC

Skills on Resume: 

• Product Development (Hard Skills)
• Product Enhancement (Hard Skills)
• Specification Development (Hard Skills)
• Regulatory Compliance (Hard Skills)
• Coordination (Soft Skills)
• Project Management (Soft Skills)
• Risk Management (Soft Skills)
• Administrative Support (Soft Skills)

Job Summary: 

• Design, develop and fabricate novel bioprinted cell-containing implantable devices that support therapeutic cell function and tissue transplant durability.
• Develop bioprinting technology to generate optimized micro-and macro-architectures of bio-printed tissues 
• Support therapeutic cell function, immune protection, vascularization, and minimized foreign body response.
• Design and test optimal surgical approaches for implantation of cellular devices.
• Perform in vitro and in vivo assays to assess device function.
• Work closely with biologists, biomaterial scientists and engineers
• Customize device composition and architectural design for specific indications, including cell therapies for metabolic disease.
• Liaise with manufacturing and regulatory team to develop stage-appropriate device manufacturing processes.
• Create SOPs, deliver experimental reports, support patent applications and present experimental results to key internal and external stakeholders.
• Contribute to the development of project milestones, timelines, and product deliverables
• Working with senior R&D management and therapeutic tissue program teams.
• Maintain clear and rigorous experimental records, including electronic laboratory notebooks.
• Become an expert user of Aspect’s microfluidic 3D bioprinting technology.

Skills on Resume: 

• Bioprinting (Hard Skills)
• Tissue Engineering (Hard Skills)
• Surgical Planning (Hard Skills)
• Experimental Assay (Hard Skills)
• Collaboration (Soft Skills)
• Regulatory Compliance (Hard Skills)
• Project Management (Soft Skills)

Job Summary: 

• Develop and maintain a quality management system for class III medical devices by phases to support the effective activities in place.
• Assess the complex medical devices for approvals, and manage internal, external and notified bodies audits.
• Manage the quality of suppliers, including quality contracts.
• Develop quality management of products from development to market launch
• Collaborate in the preparation of technical files according to the regulatory requirements.
• Review and adapt the development documents about regulatory aspects.
• Participate and support the clinical team in the development of clinical quality processes.
• Actively contribute regarding the communication with suppliers, notified bodies and other competent authorities.
• Design, implementation, deployment, training and monitoring of the company’s Document Control (DC) procedure for eQMS.
• Actively contribute to the design and implementation of the Risk Management procedure.
• Prepare, organize and record Design Reviews

Skills on Resume: 

• Quality Management System (Hard Skills)
• Regulatory Assessment (Hard Skills)
• Audit Management (Soft Skills)
• Supplier Quality (Hard Skills)
• Product Quality (Hard Skills)
• File Preparation (Hard Skills)
• Clinical Quality Support (Soft Skills)
• Communication (Soft Skills)

Job Summary: 

• Lead troubleshooting efforts, analyze complex data and drive key assay and process-related decisions
• Design and execute experiments that develop and characterize cell-based assays.
• Bringing new instruments and experimental techniques into the lab and developing assays into the R&D team
• Finding optimal conditions for primary human cell culture
• Characterizing variance and stability of assays at scale
• Identifying and developing controls for sources of variability
• Identifying and testing areas for process improvements
• Lead cross-functional efforts with scientists, software engineers, hardware engineers, and team leaders throughout the company. 
• Discuss everything from early drug development to the physics behind flow cytometry with these groups.
• Present designs and conclusions to a broad interdisciplinary audience

Skills on Resume: 

• Troubleshooting (Hard Skills)
• Experimental Design (Hard Skills)
• Technique Development (Hard Skills)
• Cell Culture Optimization (Hard Skills)
• Assay Variance (Hard Skills)
• Process Improvement (Hard Skills)
• Leadership (Soft Skills)
• Communication (Soft Skills)

Job Summary: 

• Perform tasks associated with the installation of biomedical equipment. 
• Responsible for the repair and maintenance of medical equipment.
• Train staff on the proper use of biomedical equipment.
• Supports and resolves issues with project teams.
• Liaise with vendors for the purchase of equipment and maintenance contracts.
• Preventive Maintenance Coordination with vendors for equipment.
• Provide technical support, and ensure minimum downtime.
• Work on large amounts of sensor data from various devices
• Work with different members of the team to validate and document high-quality code.
• Contribute to manuscripts for peer-reviewed journal articles to establish the biological, clinical and patient relevance of data collected in novel digital biomarker approaches.

Skills on Resume: 

• Biomedical Equipment (Hard Skills)
• Equipment Repair (Hard Skills)
• Staff Training (Soft Skills)
• Issue Resolution (Soft Skills)
• Vendor Liaison (Soft Skills)
• Coordination (Soft Skills)
• Technical Support (Hard Skills)
• Data Analysis (Hard Skills)

Job Summary: 

• Performs feasibility studies for new products or features
• Proposing design and process improvements
• Plan, execute, analyze and document experiments
• Ensures compatibility between the Idylla Platform and Idylla test menu
• Analyze the problem following appropriate scientific methodology (DOE, DMAIC, RATIO, etc.)
• Plan, execute, verify, and validate implementation of solutions
• Document progress and results and communicate to internal stakeholders
• Aid in equipment selection and planning efforts of new and existing service lines
• Work in conjunction with other Biomedical Engineer staff within the HUCCS Program and at all of MED’s Health Units
• Develop robust algorithms and use the data produced to help deepen the understanding of how impairments induced by neurological diseases impact a patient’s day-to-day life.

Skills on Resume: 

• Feasibility Study (Hard Skills)
• Process Improvement Proposal (Hard Skills)
• Platform-Test Menu Compatibility (Hard Skills)
• Problem Analysis (Hard Skills)
• Solution Planning (Hard Skills)
• Communication (Soft Skills)
• Equipment Selection (Hard Skills)

Job Summary: 

• Plan laboratory and pharmacy equipment for hospitals as well as specialized laboratory and pharmacy projects
• Definite and describe the detailed specifications of laboratory and pharmacy equipment
• Contact with suppliers, requests for proposals, and offer processing
• Responsible for internal calculation of equipment and workload
• Draft time schedules and clarify pre-installation requirements
• Supervise the installation works and organization of training of Medical Equipment on-site
• Communicate with customers such as the medical staff and the engineering department of hospitals
• Actively cooperate with other organizational units/departments
• Manage room equipment lists, draft catalogs including specifications and quantities, cost estimates preparation of the general specifications, the definition of pre-installation works, compilation and presentation of the documentation to the customer

Skills on Resume: 

• Project Management (Hard Skills)
• Technical Proficiency (Hard Skills)
• Vendor Management (Hard Skills)
• Analytics (Hard Skills)
• Documentation (Hard Skills)
• Installation Supervision (Hard Skills)
• Communication (Soft Skills)
• Collaboration (Soft Skills)