Senior Human Factors Engineer
San Francisco Metro Area, CA
ROLE AND RESPONSIBILITIES:
We are searching for a Senior Human Factors Engineer to join our Design Assurance team. They will have primary responsibility for user-centered research activities related to product design supporting company initiatives. Focusing on both user interfaces and ergonomics, this role will support product teams throughout the development lifecycle.
- Collaborate with Engineering in the Feasibility stages of Product Development to understand various aspects related to the user interface including with the product, associated apps, and labeling
- Advise Engineering early within the development stage with regards to foreseeable misuse of products and accessories
- Lead the user-based Design Validation effort, and collaborate with the Clinical team to design User Preference Studies
- Deliverables indicative of success include writing User based product requirements related to the user interface, Use FMEA s or Task Analyses in relation to a product s use, and plans, protocols and reports associated with Design Validation and/or User Preference Studies
- Collaborate with external Human Factor Engineering consultancies, internal stakeholders and partner organizations
- Write usability study protocols, perform statistical data analysis and write summary reports that are consistent with health authority expectations
- Present results of field observations, research, and usability testing to the New Product Development organization
- Reinforce a human centered design approach across the organization
- Represent the Human Factors function on core teams for large projects
- Prepare and review documentation for submission to regulatory agencies and notified bodies
- Keep abreast of regulations and best practices for medical device human factors (e.g. IEC 62366, AAMI HE75, FDA Applying Human Factors and Usability Engineering to Medical Devices) and advise management regarding potential improvements to internal processes and regulatory issues related to usability engineering
PERSONAL AND PROFESSIONAL QUALIFICATIONS:
- Minimum 5-7 years of relevant Human Factors/Usability Engineering experience in medical device, consumer electronics, or hardware product development industries
- Experience in medical device, or similar regulated industry
- Successful candidate will be a critical thinker with excellent observational and active listening skills
- Strong interpersonal and collaboration skills: Able to work with and across various groups and levels of management within the organization
- Excellent verbal communication and presentation skills
- Experience supporting HFE activities including ethnographic research, requirements definition research, requirements writing, use-related risk analyses, formative usability assessments and/or final summative design validation studies.
- Working knowledge of FDA-Recognized Standards on Human Factors in medical devices
- Bachelor s of Science degree in Human Factors Engineering, Biomedical Engineering, UX, Cognitive Psychology, Computer Science with human-computer interface (HCI) emphasis, Human Centered Design, or other related field. Advanced degree strongly preferred.