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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