Principal Human Factors Engineer

Boston Scientific•Maple Grove, MN

12h

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.