Manufacturing Lead

Remedy Robotics https://www.remedyrobotics.com/ is a medical technology company developing robotic systems for endovascular intervention. Its proprietary technology combines robotics, machine learning, and advanced computer vision to help physicians perform highly precise endovascular procedures and expand access to life-saving stroke and cardiovascular care. Initially focused on neurovascular intervention, Remedy is addressing the limited availability of specialized treatment for time-critical cardiovascular emergencies, with the long-term goal of enabling expert intervention regardless of patient location. 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 Knowledge, Skills, Abilities: - 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 Minimum Qualifications: - 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 Preferred Qualications: - 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 Benefits: - Competitive salary, including equity - 401k + company match - Health, dental, and vision insurance - 20 days PTO per year - Commuter benefits within the Bay Area - Well stocked snacks and Friday team lunches