Principal Manufacturing Engineer

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.