Boston Scientific Gruppe
Principal Human Factors Engineer - Electrophysiology
Boston Scientific Gruppe, Saint Paul, Minnesota, United States, 55199
Overview
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. 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. 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 high-visibility role that requires strong leadership, systems thinking, and expertise in usability for Class III medical devices. 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 Required qualifications
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 qualifications
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 Requisition ID: 614826 Minimum Salary: $99,100 Maximum Salary: $188,300 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific will vary based on actual location of the position and other pertinent factors. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At Boston Scientific, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non-exempt (hourly), non-sales roles may include variable compensation from time to time (e.g., overtime and shift differential) and annual bonus targets (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may include variable compensation, i.e., annual bonus targets and long-term incentives (subject to plan eligibility and other requirements). For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and better reflect the patients, customers, and communities we serve. Equal opportunity and policies
Boston Scientific Corporation is an equal opportunity employer. Recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, disability, genetic information, or any other protected class. Boston Scientific adheres to applicable COVID-19 vaccination policies where required by state or federal law. This role is considered safety-sensitive and may be subject to prohibited substance testing.
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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. 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. 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 high-visibility role that requires strong leadership, systems thinking, and expertise in usability for Class III medical devices. 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 Required qualifications
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 qualifications
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 Requisition ID: 614826 Minimum Salary: $99,100 Maximum Salary: $188,300 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific will vary based on actual location of the position and other pertinent factors. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At Boston Scientific, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non-exempt (hourly), non-sales roles may include variable compensation from time to time (e.g., overtime and shift differential) and annual bonus targets (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may include variable compensation, i.e., annual bonus targets and long-term incentives (subject to plan eligibility and other requirements). For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. At Boston Scientific, we recognize that nurturing a diverse and inclusive workplace helps us be more innovative and better reflect the patients, customers, and communities we serve. Equal opportunity and policies
Boston Scientific Corporation is an equal opportunity employer. Recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, disability, genetic information, or any other protected class. Boston Scientific adheres to applicable COVID-19 vaccination policies where required by state or federal law. This role is considered safety-sensitive and may be subject to prohibited substance testing.
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