Human Factors Engineer - Medical Device, IEC-60601, HFC Lake Forest, CA **Hybrid** Contract $65/hr - $80/hr 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. **You will receive the following benefits:** + Medical Insurance - Four medical plans to choose from for you and your family + Dental & Orthodontia Benefits + Vision Benefits + Health Savings Account (HSA) + Health and Dependent Care Flexible Spending Accounts + Voluntary Life Insurance, Long-Term & Short-Term Disability Insurance + Hospital Indemnity Insurance + 401(k) including match with pre and post-tax options + Paid Sick Time Leave + Legal and Identity Protection Plans + Pre-tax Commuter Benefit + 529 College Saver Plan Motion Recruitment Partners (MRP) is an Equal Opportunity Employer, including Veterans/Disability/Women. All applicants must be currently authorized to work on a full-time basis in the country for which they are applying, and no sponsorship is currently available. Employment is subject to the successful completion of a pre-employment screening. Accommodation will be provided in all parts of the hiring process as required under MRP’s Employment Accommodation policy. Applicants need to make their needs known in advance. **Posted by:** Kevin Gabrielson **Specialization:** UX/UI Engineer