Job Description

Human Factors Engineer

Location : Lake Forest, CA OR Fort Worth, TX (Onsite)

Exp : 8 to 10 Years

Industry : Lifesciences (Medical Devices)

Job Description: Contract Principal Human Factors Engineer Lifesciences (Medical Devices)

As a Principal Human Factors Engineer, this role will support the Surgical Instrumentation and Digital Health Suite products in Lake Forest, California, USA. The responsibilities of this position include:

• Applying user-centered design principles to research, design, and develop Digital Health Suite and Surgical Instrumentation projects.
• Utilizing Human Factors Engineering (HFE) methods and principles to create products that meet customer technical/functional specifications and manufacturing cost/efficiency requirements.
• Delivering traditional HFE activities and deliverables, such as:
  • HFE Plans
  • Task Analysis to support risk management activities
  • Planning and conducting usability evaluations
  • Cognitive walk-throughs
  • Data analysis to identify opportunities and mitigate risks
  • Reporting on formative and summative evaluation results
  • Providing proactive recommendations to product teams
• Authoring Human Factors artifacts required for regulatory compliance, including adherence to IEC 62366, AAMI HE75, and FDA guidelines on Applying Human Factors and Usability Engineering to Medical Devices.
• Collaborating with product teams to ensure optimal usability and use safety of current and future products.
• Identifying, defining, analyzing, validating, and reporting Human Factors Engineering and Usability considerations, ensuring their incorporation into the product design process.
• Advocating for end users by conducting interviews or surveys to gather information on use-related requirements, risks, needs, user profiles, task analysis, and user interfaces.
• Assessing user-interface elements and usability characteristics of current and future products, with a special emphasis on use safety.
• Translating user needs and requirements into design concepts in collaboration with product design teams.
• Staying current on state-of-the-art methods in the life sciences/medical device industry.
• Independently planning and managing activities while collaborating with multi-disciplinary teams, including design, engineering, marketing, quality, regulatory, and clinical departments.

Candidate Minimum Requirements:

• Bachelor's Degree or equivalent experience (Associate's Degree + 11 years; Master's Degree + 5 years; PhD + 4 years).
• Fluency in reading, writing, understanding, and communicating in English.
• At least 4 years of experience in delivering HFE support for medical device development (SiMD, SaMD, etc.).
• Proven experience in delivering a complete HFE file to support at least one successful FDA approval and IEC 60601-1-6 certification (IEC 62366 TRF).
• Location: Lake Forest, CA, or Fort Worth, TX (must be able to travel between sites to support projects).

Job Tags

Contract work,

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