About The Position

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

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
  • Experience interfacing with regulatory bodies and contributing to submission documentation/responses
  • Proficiency in Adobe and/or Figma
  • Strong interpersonal and consultative skills with high stakeholder empathy

Nice To Haves

  • Prior work in EP, cardiovascular, or high-risk therapeutic areas
  • Familiarity with systems engineering
  • Experience leading cross-functional teams and mentoring junior engineers
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