Senior Human Factors EngineerApply Now
Location: Lawrence, Massachusetts 01843
Employment Type: Direct Hire
- Serving as a patient / customer advocate in helping realize the vision for delivering game-changing products that are safe & effective, easy to use, not prone to use error, and provide user satisfaction; ultimately supporting our goal of extremely low burden of care
- Supporting Product Management and Product Engineering personnel in establishing ergonomic, human factors (HF), and usability-related requirements for new products and product line extensions.
- Leading and supporting ethnographic research, usability testing, individual interviews, and group interviews
- Analyzing quantitative and qualitative data to inform design decisions and risk analyses
- Contributing to user interface designs by providing heuristic design guidance, ideas, and feedback to project teams
- Leading documentation review and development, including: risk analyses, user/environment profiles, task analyses, use specifications and HFE reports to support regulatory filings
- Drafting uFMEAs; collaborating with Systems Engineering in identifying intended users and use environments, as well as potential use-related hazards
- Analyzing complaints from on-market products for usability-related issues.
- Flexibility with a range of product interfaces from software GUIs, hardware/fluid connectors to workstations
- Representing the Human Factors/Usability Engineering function on core teams for small to medium sized projects
- Collaborating with internal & external parties in planning, structuring, recruiting for, and executing formative and summative usability evaluations
- Detailed working knowledge of the implementation of all relevant HF & usability-related standards and guidance documents (ANSI/AAMI/ISO 14971, AAMI/ANSI HE75, ANSI/AAMI/IEC 62366, IEC 60601, etc.)
- Approximately 20-25% travel is expected of this position (all expenses covered)
- 5+ years’ experience in Human Factors / Usability engineering, and/or product design, development, or testing; experience with class II medical device products is preferred
- Ability to communicate and present effectively, and interface with customers in a highly professional manner
- Excellent technical communication skills and attention to detail, including creating and editing technical research, analyses, protocols, and reports
- Ability to analyze and synthesize large quantities of information into usable communications.
- Basic understanding of system, electrical, and mechanical design, as well as software integration.
- Prior experience with complex electro-mechanical systems preferred, especially systems having fluidic and/or disposable components is a bonus
- Experience leading: formative and summative usability evaluations (structuring, recruiting for, conducting, and reporting on), especially involving class II or III medical devices
- Experience working with third-party service providers and external certification laboratories is a bonus
- Working experience with medical device design and development processes that conform to standards including: ISO 9000, ISO 13485, IEC 62304, IEC 60601, IEC 62366, and ISO 14971.
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