Boston Scientific · 2 months ago
Principal Human Factors Engineer - Electrophysiology
Boston Scientific is a leader in medical science committed to solving health industry challenges. The Principal Human Factors Engineer will lead human-centered product development for complex medical devices, guiding teams in designing and validating user experiences that enhance patient care.
Health CareMedicalMedical Device
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
Qualification
Required
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
Preferred
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
Company
Boston Scientific
Boston Scientific is a medical technology company that designs and develops medical devices to diagnose and treat a wide range of condition.
H1B Sponsorship
Boston Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (114)
2024 (106)
2023 (93)
2022 (140)
2021 (111)
2020 (97)
Funding
Current Stage
Public CompanyTotal Funding
$10.02B2025-02-21Post Ipo Debt· $1.58B
2024-02-22Post Ipo Debt· $2.17B
2022-03-04Post Ipo Debt· $3.28B
Recent News
2026-01-13
2026-01-13
2026-01-13
Company data provided by crunchbase