Manufacturing & Engineering Manager

Remote (Nationwide), with approximately 25% travel to the contract manufacturer in San Diego, CA  ·  Exempt, Full-Time  · Reports to Chief Operating Officer  ·  No direct reports At Zerigo Health, we’re changing what it means to live with a chronic skin condition.Millions of Americans with psoriasis and eczema face a broken system, months-long waits for care, treatments that don’t stick, and costs that spiral out of control. We’re fixing that. Zerigo’s platform combines an FDA-cleared smart home device, AI-driven personalized care plans, and real human support to deliver clinical-grade dermatology care where people actually live, at home. Our results speak for themselves: 88% clinical success rates, 73% treatment adherence, and over $10M in savings generated for every 1,000 members on our platform.We’re a fast-growing, mission-driven team at a pivotal moment. We are energized by hard problems, improving things along the way to benefit our members and each other. If you are motivated by meaningful work and the prospect of building something that genuinely improves people’s lives, you’ll fit right in here.ABOUT THE ROLEThe Manufacturing & Engineering Manager serves as the company’s technical owner of the contract manufacturing relationship, owning the Device Master Record (DMR) for Zerigo’s connected phototherapy device. This hands-on role works closely with our contract manufacturer, translating engineering requirements into reliable manufacturing execution, leading process improvements, implementing design changes, and driving results across quality, cost, and delivery.   This role works closely with Quality, Supply Chain, Product, and Finance and owns the engineering content of DMR changes while Quality owns the change-control process and sign-off.CORE DELIVERABLESDesign & Sustaining EngineeringOwn the engineering content of changes to specifications and bills of materials (BOMs), including the rationale behind engineering change orders (ECOs). Ensure changes do not degrade reliability analysis. Review all specification changes, including those affecting embedded software.Manufacturing Line SupportProvide technical support for production-line issues as they arise, traveling to the CM for on-site troubleshooting when needed, and unlock devices for service or testing. Handle execution-level BOM updates and review work instructions for technical accuracy remotely between visits.Tooling, Fixtures & TestBuild and maintain tooling, fixtures, and calibration fixtures, and help troubleshoot production test equipment.Supplier & Partner PerformanceOversee overall performance of the contract manufacturer and major suppliers. Define and track key performance indicators (KPIs), and partner with them so production forecasts and operating budgets meet or exceed targets.Production Planning SupportWork with the contract manufacturer so inventory is appropriate to support the cross-functionally approved finance forecast.Firmware Partner LiaisonWork with Zerigo’s external firmware development partner on requirements and deliverable review. This role does not write firmware.Quality CollaborationAdvise Quality on test methods, inspection criteria, and root-cause questions, and bring manufacturing data to the monthly quality governance forum. Change control, CAPA, and product release approvals rest with Quality & Regulatory.Logistics & Special BuildsCoordinate device pack-and-ship with the contract manufacturer and support low-volume, non-clinical demo unit builds (fewer than 5 units/year).REQUIRED QUALIFICATIONS Bachelor’s degree in mechanical, electrical, or biomedical engineering (or a related field), with 7+ years of experience in manufacturing or sustaining engineering.Direct, hands-on experience with tooling, fixtures, electromechanical devices, and line support at a contract manufacturer.Experience managing contract manufacturing relationships, including defining and managing manufacturing KPIs across a cross-functional organization.Proven track record with FDA-cleared electromechanical medical devices, with experience sufficient to own a DMR.Working familiarity with Device History Record (DHR), CAPA, and ISO 13485 medical device quality requirements, enough to collaborate effectively with Quality.Comfort managing a technical vendor relationship, such as an outside firmware developer: evaluating deliverables and translating requirements without writing the code yourself.Strong communication, problem-solving, analytical, and decision-making skills, and solid financial acumen; comfort operating as a technical leader without direct reports.COMPENSATION AND BENEFITSThe expected base salary range for this role is $120,000 - $129,000, depending on experience, qualifications, and location. This role is also eligible for equity and a performance-based bonus. Zerigo Health offers a comprehensive benefits package, including medical, dental, and vision coverage; 401(k); paid time off; and more.EQUAL OPPORTUNITY Zerigo Health is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, veteran status, or any other characteristic protected by law.