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Human Factors Engineer - Medical Device, IEC-60601, HFC

Motion Recruitment
Forest, CA Full Time
POSTED ON 4/21/2025
AVAILABLE BEFORE 5/20/2025

Our client is a worldwide medical device company with an office located in South Orange County . The are urgently hiring for contract-to-hire Sr. Human Factors Engineer to work hybrid 3-4 days a week onsite in their south OC office.

As a Sr.  Human Factors this role will support the  Surgical Instrumentation and Digital Health Suite products.

  • Apply user-centered design principles to the research, design, and development of their Digital Health Suite and Surgical Instrumentation projects.
  • Apply Human Factors Engineering (HFE) methods and principles to design and develop products that meet customer technical / functional specifications as well as manufacturing cost / efficiency requirements.
  • Accountable to delivering on traditional HFE activities and deliverables such as HFE Plans, development of Task Analysis to support Risk management activities, planning and conducting usability evaluations, cognitive walk-throughs, data analysis to identify opportunities and control risks, effectively report on formative and summative evaluation results, and proactively present recommendations to product teams.
  • Author Human Factors artifacts required for regulatory compliance, specifically IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability Engineering to Medical Devices.
  • This specialized skillset works integrally with product teams to ensure optimal usability characteristics and use safety of current and future products.
  • This position serves to identify, define, analyze, validate and report on Human Factors Engineering and Usability considerations to ensure they are incorporated in the design process related to their products.
  • The position also involves advocacy for end users through the conduct of interviews or surveys of users or customers to collect information on topics such as use-related requirements, use risks, needs, user profiles, task analysis and user interfaces.
  • Additionally, the position involves needs assessment of the user-interface elements and usability characteristics of both current and future Alcon products, with special emphasis on aspects related to use safety.
  • The contracted service is accountable for ensuring user needs and requirements are translated into design concepts in collaboration with the product design teams.
  • Maintain awareness of the state-of-the-art methods as applied to life-sciences / medical device industry.
  • The contracted service is expected to plan and own their activities including collaborating with multi-disciplinary teams, including design, engineering, marketing, quality, regulatory, and clinical areas.

Candidate minimal requirements :

  • Bachelor’s Degree or Equivalent years of directly related experience (Assoc. 11 yrs; M.S. 5 yrs; PhD 4 yrs)
  • The ability to fluently read, write, understand, and communicate in English.
  • At least 4 Years of Experience delivering HFE support of medical device (SiMD, SaMD, etc) development
  • Must have delivered the full HFE file to support at least one successful medical device FDA approval and IEC 60601-1-6 certification (IEC 62366 TRF)
  • Classical education tied to human factors engineering : psychology of use, human factors, user centric design, ergonomics, etc. Prefer candidates that have majored in the topic within their education
  • Experience in at least one full, end to end, medical product development project (digital product is fine = SaMD) where they planned, lead and executed on the HFE activities and deliverables through product submissions / approvals and launch for both US and EU markets.
  • The Offer

  • 65-80 / hr CTH
  • 12 month contract with opportunity for FT employment
  • Medical, dental vision W2 benefits
  • Optional 401k
  • Motion Recruitment Partners.

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