Senior Human Factors Engineer

3 days ago

Santa Rosa, California, United States Apex Systems Full time
Senior Human Factors Engineer

We are seeking a highly skilled Senior Human Factors Engineer to join our team at Apex Systems. As a key member of our global Design and Human Factors team, you will play a critical role in advancing the needs of the MedTech industry by placing users at the center of our design process.

Our team is comprised of experts in Industrial Design, Human Factors Engineering, UX/Interaction Design, Information Design, and Design Strategy. We design solutions that span the full episode of care and balance the needs of various users, surgeons, hospital staff, patients, and caregivers.

In this role, you will influence HF/Usability strategy and lead human factors efforts for programs from concept through post-market support. You will develop a good understanding of intended use environments gained through time spent in the field and a good understanding of intended user types formed through interactions with users.

You will work on problems of diverse scope that impact broader program teams and business, leading projects requiring identification and analysis of a variety of factors. You will demonstrate judgment in selecting methods and techniques for evaluations and mentor other engineers on project.

You will also supervise and direct third-party contractors/consultants, including reviews of deliverables to ensure accuracy. You will network with key contacts outside your area of expertise, contribute to cross-functional decisions, and understand the importance of alignment and negotiation.

Requirements:
  • University/Bachelor's Degree in Human Factors Engineering (HFE), Usability Engineering, Cognitive Science, Anthropology, or Equivalent
  • Minimum of 5+ years of work experience in human factors/usability engineering, use case validation testing, or equivalent experience in product development and customer interactions
  • Demonstrated proficiency with the human factors engineering process, including research, planning, risk assessment, and regulatory submissions
  • Demonstrated ability to negotiate with stakeholders and provide disposition feedback and/or suggestions for edits or new entries to risk management documentation
  • Expertise in planning, executing, documenting, and reporting usability testing, including moderation of studies
  • Knowledge of the IEC 62366 standard and the FDA guidance on human factors engineering
  • Good knowledge of the ISO 14971 and IEC 62304
  • Medical Device product development or experience working in a highly regulated industry is a strong plus

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex, age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law.

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