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

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.