Note: The job is a remote job and is open to candidates in USA. Zerigo Health is seeking a Manufacturing & Engineering Manager to serve as the technical owner of its contract manufacturing relationship and the Device Master Record for its connected phototherapy device. The role supports manufacturing execution, engineering changes, production troubleshooting, supplier performance, and collaboration with Quality, Supply Chain, Product, Finance, and external partners.
Responsibilities
- Own 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
- Provide 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
- Build and maintain tooling, fixtures, and calibration fixtures, and help troubleshoot production test equipment
- Oversee 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
- Work with the contract manufacturer so inventory is appropriate to support the cross-functionally approved finance forecast
- Work with Zerigo’s external firmware development partner on requirements and deliverable review. This role does not write firmware
- Advise 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
- Coordinate device pack-and-ship with the contract manufacturer and support low-volume, non-clinical demo unit builds (fewer than 5 units/year)
Skills
- 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
Benefits
- This role is also eligible for equity and a performance-based bonus.
- Medical, dental, and vision coverage
- 401(k)
- Paid time off
- Remote (Nationwide), with approximately 25% travel to the contract manufacturer in San Diego, CA
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