Cambridge Recruiters is hiring: Principal Manufacturing Engineer in 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)

*MUST HAVE* - 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.
• 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 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.