Principal Manufacturing Engineer
hace 21 horas
San Mateo
Senior / Principal Manufacturing Engineer or Manager (Medical Device – Active Implantable Cardiac Startup Location: San Mateo, CA (Hybrid) Company Stage: Post–Series B, early development-stage startup Compensation: $175K–$210K base + equity (flexible based on experience and level) - MEDICAL DEVICE Manufacturing Engineering Experience About the Company We’re a venture-backed medical device startup developing a first-in-class active implantable Cardiac system that merges precision diagnostics, embedded electronics, and biocompatible materials. Fresh off our Series B funding, we’re moving from R&D prototyping to early clinical builds — and we’re looking for a hands-on manufacturing engineer/manager to make it happen! This is a rare opportunity to build manufacturing processes from the ground up for a next-generation implantable device that blends hardware, firmware, and human impact. The Role We’re seeking a Senior to Principal Manufacturing Engineer (or Manager) who will own process development, design transfer, and scale-up for our implantable system and external components. You’ll define, validate, and optimize the processes that bridge innovation and production — ensuring our device can be built with precision, reliability, and compliance. What You’ll Do Process Development & Validation • Develop and characterize manufacturing processes for implantable assemblies, hermetic housings, sensors, interconnects, and precision-machined or microelectronic subassemblies., • Lead DFM/DFA with R&D to drive scalable, high-yield design decisions., • Define and execute IQ/OQ/PQ validation protocols, capability studies (Cp/Cpk), GR&R, and statistical analyses., • Lead design transfer from R&D to production — ensuring all processes, tooling, and test methods are fully qualified., • Create assembly instructions, travelers, and work instructions for pilot and production builds., • Support pilot-line setup, including tooling, fixtures, automation concepts, and assembly aids., • Identify, qualify, and manage critical suppliers (machining, molding, coatings, microelectronics, etc.)., • Specify, source, and qualify production and assembly equipment including precision tools and environmental controls., • Own and maintain DHFs, DMRs, and process documentation in compliance with FDA QSR and ISO 13485., • Drive risk management activities (PFMEA, DFMEA) and link controls to design and process risk., • Collaborate with Quality Engineering to implement SPC systems and in-process inspection plans. Cross-Functional Leadership • Work hand-in-hand with R&D, Systems, and Quality to deliver seamless transitions from engineering to production builds., • Provide hands-on leadership during engineering builds, pilot runs, and validation phases., • Mentor junior engineers and technicians in process design, validation, and documentation best practices. What You’ll Bring • B.S. or M.S. in Mechanical, Manufacturing, Biomedical, or Electrical Engineering., • 7–10+ years of medical device manufacturing experience, including at least 3 years in active implantable, microelectronic, or electromechanical systems (e.g. IPGs, neurostim, or cardiac rhythm devices)., • Proven expertise in process development, validation (IQ/OQ/PQ), and design transfer under FDA and ISO regulations., • Deep experience with precision assembly, cleanroom operations, transducers/sensors, or PCB/electronic module integration., • Strong grasp of ISO 13485, 21 CFR 820, ISO 14971, and related standards., • Excellent communicator, cross-functional collaborator, and technical problem-solver. Local Candidates Strongly Preferred - no relocation assistance available US Citizen or Green Card Holders preferred No C2C Candidates will be considered. Must be able to work as direct-hire/W2 employee.