Human Factors Engineer
San Mateo Metro Area, CA
Human Factors Engineer
The successful candidate will provide human factors expertise and lead human factors engineering work on device development project teams developing drug delivery devices. The Human Factors Engineer will collaborate with these cross functional teams, including device engineering, regulatory, quality, clinical, program management, and marketing, to guide development of combination drug device products and ensure these products are safe and effective for use.
Major Duties and Responsibilities:
The candidate will be responsible for the following activities:
Developing human factors engineering strategies and leading HF activities on drug-device combination product program teams, including ethnography, requirements definition research, use-related risk analysis, formative usability studies, instruction and training development, and summative usability studies
Writing and reviewing HF sections for health authority submissions.
Interacting with health authorities during face to face meetings and in written responses.
Interacting with senior leaders with regards to HF strategy and implementation.
Improving internal Human Factors processes to ensure consistency, compliance and efficiency
Degree in human factors engineering, bioengineering, mechanical engineering, or related discipline. BS and a minimum of 5 years of related experience or MS and a minimum of 3 years of related experience.
The right candidate will have 5+ years experience in applying Human Factors engineering to medical device or combination product development. Years of required experience will vary based on the highest level of education completed, the level of expertise within combination products and the level of position being interviewed for.
Working knowledge of relevant human factors, design controls, and risk management regulations, standards, and guidance for medical devices and combination products
Experience working cross-functionally on risk management activities
Proven ability to clearly communicate how study results can be implemented into design
Experience working with external consultancies, or as part of an external consultancy team that supported the design and development of new medical devices
Ability to analyze data, including knowledge and proficiency with basic statistics
Other Skills and Qualifications:
Ability to communicate effectively in writing, verbally, and as a presenter
Demonstrated tie management, decision making, presentation, and organization skills
Strong interpersonal skills and the ability to collaborate actively and proactively with others in a cross-functional team
High level of initiative and ability to work independently
If you require sponsorship, please DO NOT apply!!!