Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
About the Role:
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.
Your Responsibilities Include:
- 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.
- Contributing to the project’s Usability Engineering plan.
- Designing and coordinating internal personnel for Subject Matter Expert (SME) review of concepts at varying levels of fidelity.
- Leading, moderating, analyzing data, and reporting on any formative/summative studies performed.
- Analyzing data from formative studies and writing reports.
- 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.
What We’re Looking For:
Minimum Qualifications:
- BS in Human Factors Engineering or a related field.
- Three (3) years of experience with medical device quality systems and developing Class II or Class III medical devices.
- Demonstrated knowledge, skills, and abilities in integrating human factors throughout the systems engineering lifecycle.
- Ten or more 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 Human Factors/Usability Engineering Summary Reports for FDA submission.
- Strong verbal and written communication skills.
- Travel to the MN facility will be required.
- US & International travel will be required for study execution.
Preferred Qualifications:
- Master of Science Degree in Human Factors Engineering or a related field.
- Board Certification in Human Factors (i.e., via Oxford Research Institute or Board of Certification in Professional Ergonomics).
Requisition ID: 585644
Among other requirements, Boston Scientific maintains specific prohibited substance testing requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a drug test as a pre-employment requirement.
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.
At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and it is important in our work of advancing science for life and improving patient health. That is why we stand for inclusion, equality, and opportunity for all.
Boston Scientific maintains a prohibited substance free workplace.
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