What are the responsibilities and job description for the Human Factors Engineer position at AddSource?
Human Factors Engineer
Location : Lake Forest, CA OR Fort Worth, TX (Onsite)
Exp : 8 to 10 Years
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).
