Job Description
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.
Posted By: Kevin Gabrielson
Job Tags
Contract work, Immediate start, Worldwide, 3 days per week,