Cambridge Recruiters
Principal Manufacturing Engineer (San Mateo)
Cambridge Recruiters, San Mateo, California, United States, 94409
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.
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.