About Fareon, Inc. Fareon, Inc. is a clinical-stage biophysics company based in San Francisco pioneering a new class of noninvasive therapies for brain disorders, brain injuries, and neurodevelopmental conditions. Backed by Lionheart Ventures.
About the role
Fareon is looking for an engineer who likes to run things. You will work directly with the Chief Product Officer as the second technical generalist in a fast-moving clinical-stage company, taking a large share of the day-to-day product development work off his plate: planning and running design verification and validation with outside test labs, including electrical safety, EMC, and human factors; keeping the Design History File audit-ready as we move toward FDA submission; driving design transfer and the first... Found on 1752vc Careers, the job board for startup and VC roles.
What they're looking for
- Build and maintain the V&V schedule against our verification master plan, keep the critical path to submission visible, and close gaps before they reach a stage gate
- Plan and run design verification and validation testing with external labs: write protocols, witness or execute tests, and author the reports
- Select and manage test vendors, and drive IEC 60601 electrical safety and EMC testing to a first-pass result, using pre-compliance testing where it retires risk
- Plan and run human factors and usability work under IEC 62366, from use-related risk analysis through formative and summative studies
- Maintain requirements and risk traceability from user needs through verification evidence
- Own the drawing package, bill of materials, and specifications for the Fareon Restore device, including change control through release
More about this role
About the role
Fareon is looking for an engineer who likes to run things. You will work directly with the Chief Product Officer as the second technical generalist in a fast-moving clinical-stage company, taking a large share of the day-to-day product development work off his plate: planning and running design verification and validation with outside test labs, including electrical safety, EMC, and human factors; keeping the Design History File audit-ready as we move toward FDA submission; driving design transfer and the first production lots with our contract manufacturer; and owning the drawing package, bill of materials, and build documentation for our device. You will also spend real time on the bench: calibrating, debugging, and refurbishing devices, supporting experiments in the Fareon lab, and packing and shipping units to clinical sites.
This is not primarily a coordination role. There is no engineering team to delegate to, although we have partnered with a capable group of local consultants. You will make technical calls daily, with the CPO as backstop on design control decisions, and you will be judged on whether the device is built, tested, documented, and shipped, not...
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