Role: R&D Engineer Human Factors
Location: Santa Clara, CA
Duration: 12 Months
- Proven ability to work with multidisciplinary teams that may include other human factors expert
- Proven ability to interface with customers in a highly professional manner
- Proven ability to apply user-centered design and human factors/usability engineering principles to Product research, development and design
- Experience in medical device development
- Ability to quickly assimilate advanced domain knowledge
- Excellent verbal and written communication and presentation skills
- Experienced R&D Engineer_Human Factors to apply human factors and ergonomics expertise to the definition, design, and evaluation of products within the R&D division of Electrophysiology Systems, which is part of the Atrial Fibrillation business unit.
- Apply knowledge of human factors principles (human performance and limitations perceptual, cognitive, motor skills, anthropomorphic) and techniques (knowledge acquisition, user-interface design, usability evaluation) to cardiac electrophysiology systems product development
- Organize and direct the work of staff and outside consultants working on human factors tasks to effectively and efficiently support product development efforts within the organization.
- Deliverables include, but are not limited to: Usability engineering files; Task analyses; Usability risk analyses; Usability testing throughout the product development process, from formative testing of early prototypes through usability validation of final designs.
- Develop collaborative working relationships with other functions across the organization, including but not limited to the following
- Work with regulatory affairs to develop strategies for new product submissions, create submission packages, and respond to questions from regulatory agencies
- Work with design quality to ensure that the company s usability engineering processes and methodologies meet and surpass the latest expectations of regulatory agencies and provide tangible value for our customers and our business.
- Keep abreast of regulations and best practices for medical device human factors (e.g. IEC 62366, AAMI HE75, ISO 14971, and the latest FDA guidance on applying human factors engineering) and advice management regarding potential improvements to internal processes and regulatory issues related to human factors engineering
- Represent in meetings with regulatory agencies, at human factors professional meetings and conferences, and as a member of standards committees.
Education & Experience:
- M.S. degree in Human Factors Engineering or Cognitive Psychology or M.S. degree in Biomedical Engineering with extensive human factors coursework
- Minimum of 5 years of relevant human factors/usability engineering experience in hardware-software systems product development; prefer 10+ years experience