Principal Human Factors Engineer
About The Position
Boston Scientific is seeking a highly motivated and experienced Principal Human Factors Engineer to apply HFE principles to complex products throughout the development lifecycle. The successful candidate will utilize a variety of new and proven technologies to deliver life-changing medical devices to patients and clinicians in support of the Interventional Cardiology division. Be a part of one of Boston Scientific’s most product-diverse divisions, supporting R&D in the design of exciting new products and business development activities. These products adhere to industry standards and include computing devices, single-use devices, and support devices.
Requirements
- BS in Human Factors Engineering or a related field.
- 8+ years of experience with medical device quality systems and developing Class II or Class III medical devices.
- Demonstrated knowledge, skills, and abilities in integration of human factors throughout the systems engineering lifecycle.
- 8+ years of experience in Human Systems Integration or Human Factors Engineering performing the following:
- Writing Usability Engineering Plans.
- Task Analysis & Use Error Analysis.
- Requirements development.
- Authoring usability protocols, screeners, and moderator guides.
- Study execution (formative and summative), including moderation, data collection, and simulated use testing.
- Ability to analyze data and write reports.
- Anchoring findings and recommendations in consensus national and international standards for usability and human-centered design.
- Risk assessment and trade-off analyses in all phases of the systems engineering lifecycle.
- Writing up Human Factors/Usability Engineering Summary Reports for FDA submission.
- Travel to the MN facility will be required.
- US & International travel will be required for study execution.
Nice To Haves
- Master of Science Degree in Human Factors Engineering or a related field.
- Strong verbal and written communication skills.
- Board Certification in Human Factors (i.e., via Oxford Research Institute or Board of Certification in Professional Ergonomics).
Responsibilities
- Understanding the clinical domain and technical knowledge of the system/device to be evaluated.
- Leading Task Analysis activities.
- Contributing to cross-functional discussions on Use Error Analysis.
- Participating in cross-functional discussions to develop a Use Specification.
- Contribute to the project’s Usability Engineering plan.
- Design and coordinate internal personnel for Subject Matter Expert (SME) review of concepts at varying levels of fidelity.
- Lead, Moderate, Analyze Data, and report out on any Formative/Summative.
- Studies performed:
- Studies will be performed in person and travel will be required.
- Analyzing the data from formative studies and writing the report.
- Planning Formative and Summative Usability Studies based on results from SME Reviews.
- Working with the Study Coordinator when recruiting Health Care Professionals for testing.
- Authoring the Human Factors/Usability Engineering Summary Report.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
