Systems Engineering, Medical Devices

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. The company’s Fareon RestoreTM platform delivers proprietary Microtesla Magnetic Therapy (MMT), precisely calibrated electromagnetic fields designed to activate biological pathways associated with resolution of inflammation and oxidative stress, repair, and recovery in the brain. The lead program targets cognitive impairment related to Long COVID, a substantial unmet need in neurology for which there are currently no approved treatments. Fareon is advancing late-stage clinical development of this first indication while expanding a broader pipeline enabled by the shared Fareon Restore platform.

Fareon is entering a defining phase of growth as it executes on the multicenter pivotal RECLAIM trial while building the clinical and organizational foundation required to bring a first-in-class biophysics platform through marketing authorization and commercialization. Beyond Long COVID, Fareon is expanding development into brain disorders marked by neuroinflammation and oxidative stress, including post-concussion syndrome, mild cognitive impairment, Alzheimer’s disease, and autism spectrum disorder.

We are a team of passionate, high-achieving professionals driven by scientific rigor, curiosity, and meaningful impact. Our culture emphasizes collaboration, clarity, accountability, and continuous learning.

Our values include:

• Meaningful Work: We do work that inspires, excites, and energizes us, and we strive for outcomes that have a positive impact on humanity.
• Meaningful Relationships: We build meaningful relationships through genuine care for one another. We use tools to navigate conflict. We don’t take ourselves too seriously.
• Curiosity: We harness curiosity to learn rapidly, consider diverse perspectives, and challenge assumptions.
• Failing Well: We celebrate “good failures” openly and emphasize failing fast. This allows us to take strategic risks and learn quickly.
• Clarity: We prioritize clear goals for individuals, teams, and the company as a whole.
• Integrity and Trust: We are a team of high integrity individuals who trust each other to do outstanding work.

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 on whether the status report is current.

Deep expertise in mechanical design, electronics, or electromechanical systems is the foundation; breadth across systems engineering, verification, manufacturing, quality, and program execution is what makes the role work. If you have been the person at a small device company who could draw the part, source it, test it, write the report, and talk to the contract manufacturer in the same week, this is that job with more scope and better science.

Priorities for the first six months, in order: (1) a verification and validation program on a credible schedule, with protocols written, test labs engaged, and the critical path to submission visible; (2) human factors work through the formative study; (3) design transfer and first production lots with our contract manufacturer, on schedule and fully documented; (4) a Design History File that is audit-ready at every stage gate. Lab support and software scope expand as these stabilize. Some of your time may also be allocated to supporting the Head of Research with projects in the Fareon lab, including grant-funded programs, as needed.

You will be based in or near San Francisco and work a hybrid schedule with three to four days per week in our office and lab in Potrero Hill, and more during builds, test campaigns, and ship weeks.

Responsibilities

Verification, Validation, and Human Factors

• 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

Product Development and Design Transfer

• Own the drawing package, bill of materials, and specifications for the Fareon Restore device, including change control through release
• Drive design transfer to our contract manufacturer through first production lot: process documentation, acceptance criteria, first article inspection, and DFM feedback into the design
• Resolve build and yield issues on the manufacturing floor and at component suppliers, in person when it matters

Device Build, Test, and Field Support

• Calibrate, test, pack, and ship devices to clinical sites and partners
• Debug, repair, and refurbish devices, remotely and in person, and feed what you learn back into the design and the DHF
• Maintain fleet records: configuration, calibration status, service history, and field complaints

Design Controls and the Design History File

• Own the Design History File for the device; the CPO signs design control decisions, you make sure the file supports them
• Organize and run stage gate reviews, capture decisions, and close action items
• Serve as the program-level point of contact for our regulatory and quality lead during audits and submission preparation

Lab and Grant Program Support

• As needed, help the research team plan and run projects in the Fareon lab, including grant-funded programs, with timelines, resources, and deliverables

Program Execution

• Maintain the integrated program timeline across contract manufacturer, component suppliers, external engineering partners, and software developers; flag risks early and drive open issues to closure
• Track statements of work, deliverables, and invoices against plan, and escalate when commitments slip
• Keep our external mobile app and dashboard developers on cadence, with requirements, decisions, and changes documented; no software background required beyond the ability to read a sprint board and write a clear requirement
• Build the lightweight templates, trackers, and meeting rhythms a small team needs, and prepare program summaries for board, investor, and grant updates as needed

What success in the first 12-24 months looks like

• First production lots delivered from our contract manufacturer on schedule, with a complete transfer package and no open first-article nonconformances
• IEC 60601 safety and EMC testing passed and the human factors formative study complete, on the schedule the submission requires
• Design verification complete and reported, with the Design History File audit-ready at every stage gate and no audit findings attributable to program records
• Devices at every clinical site calibrated, documented, and supported, with field issues resolved in days or hours rather than weeks
• A program toolkit in place that gives the CPO and CEO current status without asking for it
• Responsibilities expanded on your own initiative because you saw the need before anyone assigned it

Required Qualifications

• BS or MS in Mechanical, Electrical, or Biomedical Engineering, or equivalent demonstrable practice; we care about what you have built
• At least 4 years of hands-on product development of physical products, with at least two years on a medical device or other regulated product (depth and range of experience will be weighted more than years)
• Production-level fluency in at least one of: mechanical CAD (SolidWorks, Creo, or Onshape) with GD&T and drawing release; or electronics design and debug (schematic capture, board bring-up, bench instrumentation)
• Have personally taken a product through design transfer to a contract manufacturer, or been the engineering point of contact for one
• Have personally authored or maintained Design History File content (requirements, risk analysis, verification protocols and reports) on a program run under ISO 13485 design controls
• Have personally planned and executed design verification testing, including work with external test labs
• Comfortable on a bench with an oscilloscope, a torque driver, and a label printer in the same afternoon
• Able to run several concurrent workstreams independently, with the judgment to distinguish what matters from what merely looks urgent
• Writes clearly, runs a meeting without being asked to, and can distill a cross-disciplinary program into one page for executives and partners
• Energized rather than unsettled by a nimble and adaptive company supported by external resources, where the plan changes as the company learns

Preferred Qualifications

• Ownership of a Design History File through FDA submission (510(k), De Novo, PMA)
• Experience with electromagnetic, RF, or precision analog hardware, or with devices that require calibration in the field
• Clinical-stage device experience, including trial device supply, site training, and field support
• Experience supporting grant-funded research, including milestone and budget reporting to federal or foundation sponsors
• Hands-on experience with IEC 60601 safety and EMC testing, IEC 62366 human factors studies, or ISO 14971 risk management; familiarity with IEC 62304

Opportunities for Growth and Advancement

Fareon is at the beginning of its scaling journey. The person who takes this role and excels will be positioned to grow into senior program leadership, as the organization expands through the pivotal trial and into the next products.

Compensation and Equity

Competitive base salary commensurate with experience, plus meaningful early-stage equity and full benefits. As an early hire in a Series A company, you will have significant influence on technical execution and team culture.

Why Fareon

• First-mover in a novel biophysics approach to brain repair, with improvements across multiple cognitive domains and emotional wellbeing in a randomized, sham-controlled pilot trial
• A real device, with real physics, that you will hold in your hands and ship to patients
• Platform architecture creates compounding value across every new indication
• Public Benefit Corporation structure aligns mission with incentives
• Small, senior team where your work directly shapes the product and the company

Anticipated Start Date: Immediately

Location: San Francisco, CA. Hybrid, with three to four days per week in our office and lab in Potrero Hill.

To apply: Include your CV and a short cover letter. In the cover letter, tell us about one physical thing you designed, built, or fixed in the last three years. Please be prepared to provide three professional references.