- Influences HF/Usability strategy and leads human factors efforts for programs from concept through post market support, supporting and influences usability activities for product lines and programs with minimal oversight.
- 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.
- Work on problems of diverse scope that impact broader program team and business and leads projects requiring identification and analysis of a variety of factors, demonstrating judgment in selecting methods and techniques for evaluations.
- Mentor other engineers on project and supervises/directs third party contractors/consultants; including reviews of deliverables to ensure accuracy.
- Network with key contacts outside own area of expertise, contributes to cross functional decisions; understands importance of alignment and negotiation, representing the voice of the customer from a human factors and technical application perspective for new product development.
- University/Bachelor's Degree in in Human Factors Engineering (HFE), Usability Engineering, Cognitive Science, Anthropology or Equivalent
- Minimum of 5+ years' work experience in human factors/usability engineering experience/use case validation testing or equivalent experience in product development and customer interactions is required.
- 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
- 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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Senior Human Factors Engineer - Santa Rosa, United States - Apex Systems
Description
Apex Systems is seeking a Senior Human Factors Engineer to join our client, a leader in the medical device industry. This position will be onsite 3 days per week in Santa Rosa, CA. It is a 6 month contract-to-hire role.
Job Summary:
Our global Design and Human Factors team focuses specifically on advancing the needs of the MedTech Industry by placing our users at the center of our design process.
We design solutions that span the full episode of care and balance the needs of various users, surgeons, hospital staff, patients, and caregivers.
Our team is comprised of Industrial Designers, Human Factors Engineers, UX/Interaction Designers, Information Designers and Design Strategists in over seven locations around the world.
Responsibilities:
Requirements:
