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, balancing the needs of various users, surgeons, hospital staff, patients, and caregivers.

As a Senior Human Factors Engineer, 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 and user types through interactions with users.

You will work on problems of diverse scope that impact the broader program team and business, leading projects requiring identification and analysis of various factors. You will mentor other engineers on projects and supervise/direct third-party contractors/consultants, reviewing deliverables to ensure accuracy.

You will network with key contacts outside your area of expertise, contributing to cross-functional decisions and understanding the importance of alignment and negotiation. You will represent the voice of the customer from a human factors and technical application perspective for new product development.

Requirements:
  • University/Bachelor's Degree in Human Factors Engineering, 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
  • Clinical experience and/or professional experience/degrees in software development and/or GUI development is a strong plus


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