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Principal Human Factors Engineer - Electrophysiology at Boston Scientific Corporation Malaysia

Waltham, Massachusetts, United States -

Full Time

Start Date

Immediate

Expiry Date

16 Apr, 26

Salary

0.0

Posted On

16 Jan, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Human Factors Engineering, Usability Engineering, User Experience Design, Human Computer Interaction, Cognitive Science, Psychology, Medical Device Usability Standards, Regulatory Guidelines, Usability Evaluation Methods, Hazard Analysis, Risk Management, Critical Thinking, Collaboration, Interpersonal Skills, Adobe, Figma

Industry

Medical Equipment Manufacturing

Description

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 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

The Principal Human Factors Engineer will lead the human factors engineering efforts for electrophysiology medical devices, ensuring compliance with usability standards and regulatory guidelines. This role involves collaborating with cross-functional teams and mentoring junior engineers.