Manufacturing Engineer
Job in
Marlborough, Middlesex County, Massachusetts, 01752, USA
Listed on 2026-03-03
Listing for:
IPG Photonics Corporation
Full Time
position Listed on 2026-03-03
Job specializations:
-
Engineering
Manufacturing Engineer, Quality Engineering, Medical Device Industry, Process Engineer -
Manufacturing / Production
Manufacturing Engineer, Quality Engineering, Medical Device Industry
Job Description & How to Apply Below
Job Summary
We are looking for a hands-on Manufacturing Engineer to support the production of laser-based medical systems. This role sits right at the intersection of engineering, manufacturing, and quality - owning process robustness, documentation, and execution in a regulated medical device environment.
If you like being on the floor, tightening processes, writing solid documentation, and supporting new products from early builds through production ramp - this is your lane.
Key Responsibilities
* Support day-to-day manufacturing of laser-based medical systems, including optical adapters and sub-assemblies
* Develop, write, and maintain manufacturing work instructions, SOPs, and visual aids in compliance with FDA and ISO requirements
* Author, execute, and support process validation activities including IQ / OQ / PQ
* Partner closely with Quality to support deviations, NCMRs, CAPAs, and continuous improvement initiatives
* Support New Product Introduction (NPI) activities, including:
* Process development and transfer from R&D to Manufacturing
* Pilot builds, design for manufacturability (DFM), and production ramp-up
* Identify and implement process improvements to improve yield, cycle time, and product quality
* Provide hands-on support to technicians during builds, troubleshooting, and training
* Maintain accurate manufacturing documentation within PLM systems (Arena experience a plus)
* Bachelor's degree in Manufacturing, Mechanical, Biomedical, or related Engineering discipline
* Minimum 3 years of experience in a medical device manufacturing environment
* Strong working knowledge of:
* FDA QSR / ISO 13485 environments
* Process documentation and controlled manufacturing records
* IQ / OQ / PQ validation methodologies
* Experience supporting production of electro-mechanical, optical, or laser-based systems
* Comfortable working on the manufacturing floor and collaborating cross-functionally
Preferred / Nice-to-Have
* Experience with Arena PLM software
* Prior experience supporting optical assemblies or laser-based products
* Experience supporting manufacturing scale-up and process transfer
What Success Looks Like in This Role
* Clear, robust, and compliant work instructions that technicians actually use
* Smooth execution of validations with minimal rework
* Strong partnership with Quality and Operations
* Faster, cleaner NPI transitions into production
* Fewer surprises on the production floor
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