Senior / Principal Manufacturing Engineer or Manager (Medical Device Active Implantable Cardiac Startup
Location : San Mateo, CA (Hybrid)
Company Stage : PostSeries B, early development-stage startup
Compensation : $175K$210K base + equity (flexible based on experience and level)
- MUST HAVE
- MEDICAL DEVICE Manufacturing Engineering Experience
About the Company
Were 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 , were moving from R&D prototyping to early clinical builds and were 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
Were 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. Youll define, validate, and optimize the processes that bridge innovation and production ensuring our device can be built with precision, reliability, and compliance.
What Youll 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.Establish robust process controls, documentation, and routers for ISO Class 7 / 8 cleanroom assembly.Design Transfer & Scale-Up
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.Partner with contract manufacturers (CMs) to develop, qualify, and scale manufacturing processes.Supplier & Equipment Management
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.Perform technical audits , drive supplier improvements, and lead corrective actions.Quality, Compliance, and Documentation
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 Youll Bring
B.S. or M.S. in Mechanical, Manufacturing, Biomedical, or Electrical Engineering.710+ 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.
