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Principal Human Factors Engineer - Electrophysiology at Boston Scientific Corporation Malaysia
Arden Hills, Minnesota, United States -
Full Time

Start Date

Immediate

Expiry Date

02 Mar, 26

Salary

0.0

Posted On

02 Dec, 25

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

No

Skills

Human Factors Engineering, Usability Engineering, Cognitive Science, Medical Device Development, Usability Standards, Regulatory Guidelines, User Research, Risk Analysis, Organizational Skills, Collaboration, Critical Thinking, Interfacing with Regulatory Bodies, Cross-Functional Teams, Mentoring, Stakeholder Empathy

Industry

Medical Equipment Manufacturing

Description
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 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
Responsibilities
The Principal Human Factors Engineer will lead the human factors engineering efforts for electrophysiology medical devices. This role involves collaborating with cross-functional teams to ensure compliance with usability standards and regulatory guidelines.