Principal Human Factors Engineer - Electrophysiology

bostonscientific•Waltham, MA

10d•$106,800 - $202,900

About The Position

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: 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 which incorporates new and existing products. 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 skills, systems thinking, and expertise in usability for Class Ill medical devices.

Requirements

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

Nice To Haves

Experience interfacing with regulatory bodies and contributing to submission documentation/responses
Prior work in EP, cardiovascular, or high-risk therapeutic areas
Proficiency in Adobe and/or Figma
Familiarity with systems engineering
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, 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