Principal Human Factors Engineer - Electrophysiology

About the role:

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 including capital equipment, single‑use devices and software/graphic user interfaces. You will serve as the strategic and tactical HFE lead on high‑impact projects, collaborating closely with cross‑functional teams including Systems Engineering, hardware and software development, Design, Quality/Design Assurance and Upstream Marketing.

Reporting to the Manager of the Human Factors and User Experience group, you will guide product teams in the design, evaluation, use risk management, validation and documentation of safe, effective, and intuitive user experiences across a complex System of Systems that incorporates new and existing products. Your insights will directly influence the success of next‑generation EP solutions that transform patient care globally.

• Serve as the Human Factors Engineering lead on assigned programs, owning the HFE strategy, scope and execution throughout the product development lifecycle.
• Champion the Human Factors and UX function across the organization.
• Mentor junior team members and contribute to continuous improvement of HFE processes and procedures.
• Advocate for the user throughout product development, ensuring designs align with cognitive, physical, and environmental use contexts.
• Understand EP use scenarios, map clinical workflows and create detailed task analyses.
• Conduct heuristic evaluations, cognitive walkthroughs, and expert reviews as needed to support concept development.
• Define, refine, and substantiate usability‑related design inputs including User Needs, System Requirements and Design Specifications.
• Work with internal and/or external design resources to define and iterate user interfaces.
• Conduct formative evaluations at appropriate points in the development process using a range of methods and prototype fidelity to support down‑selection, derisk/guide design decisions and ensure implementation is usable, safe and effective.
• Collaborate with systems owners and designers to integrate HFE and user feedback into the design.
• Own Use Risk Analyses and identify potential use risk mitigations.
• Plan, execute and document Summative Usability evaluations and User Needs validation.
• Support the Design Assurance team in design controls traceability and design validation.
• Develop and maintain high‑quality usability engineering file documentation in alignment with regulatory standards (e.g., IEC 62366, MDR, FDA Guidance).
• Collaborate globally across R&D teams to deliver world‑class user experiences.

• Bachelor’s or Master’s degree in Human Factors Engineering, Usability Engineering, User Experience Design, Human Computer Interaction, Cognitive Science, Psychology or a related field.
• Minimum of 8 years’ experience in medical device Human Factors Engineering.
• 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, ISO 14971, HE75).
• Demonstrated expertise in Human Factors for Class Ill medical devices.
• Excellent written, verbal and visual communication skills whether interacting with development teams, leadership or clinicians/users.
• In‑depth understanding of usability evaluation methods, hazard analysis and use risk management.
• Strong organizational skills with attention to detail.
• Proven ability to work independently while promoting strong collaboration.
• Comfortable working in fast‑paced and dynamic environments across multiple projects.
• Critical thinking skills with the ability to analyze alternatives and recommend solutions.
• Ability and willingness to travel as needed.

• Experience interfacing with regulatory bodies and contributing to submission documentation/responses.
• Prior work in EP, cardiovascular, or high‑risk therapeutic areasli>
• Proficiency in Adobe and/or Figma.
• Familiarity with systems engineering.
• Experience leading cross‑functional…