Systems Engineering, Medical Devices

Fareon•San Francisco, CA

2d•Hybrid

About The Position

Fareon is seeking a hands-on systems engineer to serve as the second technical generalist at a fast-moving clinical-stage medical device company. The role works directly with the Chief Product Officer and takes substantial responsibility for day-to-day product development, including verification and validation with external test labs, human factors work, Design History File readiness, design transfer, early production, and device documentation. It combines deep expertise in mechanical design, electronics, or electromechanical systems with broad ownership across systems engineering, verification, manufacturing, quality, and program execution. This is an individual-contributor role with no engineering team to delegate to, supported by local consultants. The engineer will make technical decisions, with the CPO as a backstop on design control decisions, and will be accountable for building, testing, documenting, and shipping the device. Hands-on work includes calibrating, debugging, repairing, and refurbishing devices, supporting lab experiments, and preparing devices for clinical sites. Initial priorities include establishing a credible verification and validation schedule, completing human factors formative work, transferring the design and producing initial lots with the contract manufacturer, and keeping the Design History File audit-ready. The role may also support the Head of Research with Fareon lab projects, including grant-funded programs. The position is based in or near San Francisco and follows a hybrid schedule, generally three to four days per week in the Potrero Hill office and lab, with additional onsite time during builds, test campaigns, and shipping weeks. Success over the first 12–24 months includes delivering documented production lots on schedule, passing IEC 60601 safety and EMC testing, completing the required human factors formative study and design verification, maintaining an audit-ready Design History File, and providing timely support to devices at clinical sites. The role offers the opportunity to grow into senior program leadership as Fareon scales through its pivotal trial and future products.

Requirements

BS or MS in Mechanical, Electrical, or Biomedical Engineering, or equivalent demonstrable practice.
At least 4 years of hands-on physical product development experience, including at least two years on a medical device or other regulated product.
Production-level fluency in at least one of the following: mechanical CAD (SolidWorks, Creo, or Onshape) with GD&T and drawing release; or electronics design and debug, including schematic capture, board bring-up, and bench instrumentation.
Personal experience taking a product through design transfer to a contract manufacturer, or serving as the engineering point of contact for one.
Personal experience authoring or maintaining Design History File content—such as requirements, risk analysis, and verification protocols and reports—on a program run under ISO 13485 design controls.
Personal experience planning and executing design verification testing, including work with external test laboratories.
Comfort working at a bench with equipment such as an oscilloscope, torque driver, and label printer.
Ability to independently run several concurrent workstreams and distinguish important work from apparent urgency.
Clear writing and meeting facilitation skills, with the ability to distill a cross-disciplinary program into a one-page summary for executives and partners.
Comfort and energy working in a nimble, adaptive company supported by external resources, where plans change as the company learns.

Nice To Haves

Ownership of a Design History File through an FDA submission, such as 510(k), De Novo, or PMA.
Experience with electromagnetic, RF, or precision analog hardware, or devices requiring field calibration.
Clinical-stage medical 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.

Responsibilities

Build and maintain the verification and validation schedule against the verification master plan, make the critical path to submission visible, and close gaps before stage gates.
Plan and run design verification and validation testing with external laboratories, including writing protocols, witnessing or executing tests, and authoring reports.
Select and manage test vendors and drive IEC 60601 electrical safety and EMC testing, using pre-compliance testing where useful to retire risk.
Plan and conduct 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 device drawing package, bill of materials, and specifications, including change control through release.
Drive design transfer to the contract manufacturer through the first production lot, including process documentation, acceptance criteria, first article inspection, and design-for-manufacturing feedback.
Resolve build and yield issues on the manufacturing floor and with component suppliers, in person when needed.
Calibrate, test, pack, and ship devices to clinical sites and partners.
Debug, repair, and refurbish devices remotely and in person, and feed findings back into the design and Design History File.
Maintain fleet records covering configuration, calibration status, service history, and field complaints.
Own the device Design History File and ensure it supports design control decisions made by the CPO.
Organize and run stage gate reviews, record decisions, and close action items.
Serve as the program-level point of contact for the regulatory and quality lead during audits and submission preparation.
As needed, help the research team plan and run Fareon lab projects, including grant-funded programs, with timelines, resources, and deliverables.
Maintain the integrated program timeline across the contract manufacturer, component suppliers, external engineering partners, and software developers; flag risks and drive issues to closure.
Track statements of work, deliverables, and invoices against plan, and escalate slipping commitments.
Keep external mobile app and dashboard developers on cadence, documenting requirements, decisions, and changes.
Create lightweight templates, trackers, and meeting rhythms for the team, and prepare program summaries for board, investor, and grant updates as needed.