Manufacturing Lead
Job in
San Francisco, San Francisco County, California, 94199, USA
Listed on 2026-06-02
Listing for:
Remedy Robotics, Inc
Full Time
position Listed on 2026-06-02
Job specializations:
-
Engineering
Manufacturing Engineer, Medical Device Industry, Quality Engineering -
Manufacturing / Production
Manufacturing Engineer, Medical Device Industry, Quality Engineering
Job Description & How to Apply Below
Headquartered in San Francisco, Remedy is backed by DCVC, Blackbird, and Tony Fadell's Build Collective, among others.
We are looking to hire a Manufacturing Lead for our Hardware Team.
What You'll Do:
- Lead manufacturing engineering from prototype through production for Remedy's disposable instruments and surgical robotic system
- Drive design transfer, DFM/DFA, supplier qualification, and production process development across molding, assembly, packaging, sterilization, and test fixturing
- Execute manufacturing validation activities (IQ/OQ/PQ) and maintain manufacturing documentation required under ISO 13485 and for IDE submissions
- Define and improve manufacturing KPIs including yield, cost, lead time, and defect rates
- Build and scale Remedy's manufacturing and operations team as the product matures
- Proven experience leading Class II and/or Class III medical devices from R&D through production
- Strong expertise in design transfer, process validation (IQ/OQ/PQ), and maintenance of ISO 13485-compliant manufacturing documentation
- Demonstrated success managing contract manufacturers and component suppliers within fast-paced startup environments
- Ability to operate effectively in a hands-on capacity while scaling and developing manufacturing teams over time
- Excellent cross-functional communication skills with a proactive approach to Design for Manufacturability (DFM), providing early-stage engineering feedback throughout product development rather than after final design completion
- 8+ years of hands-on experience in manufacturing engineering and operations leadership within the medical device industry
- Bachelor's or Master's degree in Mechanical Engineering, Manufacturing Engineering, or a related field
- Experience manufacturing disposable medical devices, including injection molding, sterile barrier packaging (ISO 11607), and EO or gamma sterilization validation
- Experience developing or scaling catheter or guidewire assembly processes
- Experience with electromechanical or capital equipment manufacturing in regulated environments
- Experience supporting FDA inspections, audits, or regulatory compliance activities
- Background in Lean Manufacturing or Six Sigma methodologies applied to low-volume, high-mix production environments
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