Principal Human Factors Engineer - Electrophysiology
About The Position
As a Principal Human Factors Engineer (HFE) within Boston Scientific’s Electrophysiology (EP) division, you will shape the vision and execution of human-centered product development across a diverse portfolio of complex medical devices. You will serve as the strategic and tactical HFE lead on high-impact projects, collaborating closely with cross-functional teams including Systems Engineering, Product Development, Design Assurance, Risk Management, and Marketing. Reporting to the Lead of the Human Factors and Usability Experience group, you will guide product teams in the design and validation of safe, effective, and intuitive user experiences. Your insights will directly influence the success of next-generation EP solutions that transform patient care globally. This is a critical, high-visibility role that requires strong leadership, systems thinking, and expertise in usability for Class III medical devices.
Requirements
- Bachelor’s or Master’s degree in Human Factors Engineering, Usability Engineering, Cognitive Science, or a related field
- Minimum of 8 years' experience in Human Factors Engineering, preferably in medical device development
- Experience with complex systems that include both hardware and software components
- Strong knowledge of medical device usability standards and regulatory guidelines (e.g., IEC 62366, FDA HF Guidance)
- Demonstrated expertise in Human Factors for Class III medical devices
- Excellent written and verbal communication skills
- Proficient in usability evaluation methods, user research, and risk analysis
- Strong organizational skills with attention to detail
- Proven ability to work independently while promoting strong collaboration
- Comfortable working in fast-paced and dynamic environments
- Critical thinking skills with the ability to analyze alternatives and recommend solutions
- Ability and willingness to travel as needed
Nice To Haves
- Experience interfacing with regulatory bodies and contributing to submission documentation
- Prior work in EP, cardiovascular, or high-risk therapeutic areas
- Familiarity with systems engineering and design control processes
- Experience leading cross-functional teams and mentoring junior engineers
- Strong interpersonal and consultative skills with high stakeholder empathy
Responsibilities
- Serve as the Human Factors Engineering lead on assigned programs, owning the HFE strategy and execution
- Define, refine, and substantiate usability-related product requirements
- Scope and lead all HFE activities throughout the product development lifecycle
- Lead task analyses, user research, and workflow mapping
- Create usability plans, use scenarios, and usability risk analyses
- Conduct and document formative and summative usability evaluations
- Develop usability engineering files and Human Factors Validation reports
- Collaborate with systems owners and designers to integrate HFE feedback into the design
- Review and critique designs for usability, safety, and effectiveness
- Identify and mitigate user-related risks
- Support the Design Assurance team to ensure design traceability and validation
- Partner with Risk Management to develop safety analyses and reports
- Advocate for the user throughout product development, ensuring designs align with cognitive, physical, and environmental use contexts
- Utilize both qualitative and quantitative data to inform design decisions
- Apply heuristics evaluations, cognitive walkthroughs, and expert reviews
- Develop and maintain high-quality documentation in alignment with regulatory standards (e.g., IEC 62366)
- Mentor junior team members and contribute to continuous improvement of HFE best practices
- Collaborate globally across R&D teams to deliver world-class user experiences
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
