AP
Product Development Engineer
Accepting applicationsACE Partners · Irvine, CA
Full-Time Mid_senior aiate
Posted
7 May
Category
Manufacturing
Experience
Mid_senior
Country
United States
Product Development Engineer
Irvine, CA | On-Site
I’m currently supporting a growing medical device company in Irvine that’s developing innovative Class III technologies and expanding its engineering team.
They’re looking for a Manufacturing / Product Development Engineer who can operate across both new product development and manufacturing engineering activities - someone comfortable working closely with R&D while also driving process development, scalability, and commercialization efforts.
This is a highly visible role within a collaborative environment where engineering has a direct impact on product success and patient outcomes.
Key responsibilities include:
Supporting development and transfer of Class III medical devices into manufacturing
Process development, validation, and continuous improvement initiatives
Design for manufacturability (DFM) and engineering change activities
Cross-functional collaboration with R&D, Quality, Regulatory, and Operations
Root cause investigations, troubleshooting, and CAPA support
Developing manufacturing documentation, work instructions, and test methods
Supporting verification/validation and product scale-up activities
Ideal background:
3+ years of engineering experience within medical devices
Experience supporting Class III products preferred
Exposure to product development and manufacturing engineering environments
Strong understanding of GMP/FDA regulated environments
Hands-on mindset with strong problem-solving capabilities
Experience with process validation, NPI, or sustaining engineering activities is a plus
The company offers strong technical exposure, exciting technology, and the chance to work on products making a real impact in the market.
If you’d be interested in hearing more, feel free to message me directly.
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Irvine, CA | On-Site
I’m currently supporting a growing medical device company in Irvine that’s developing innovative Class III technologies and expanding its engineering team.
They’re looking for a Manufacturing / Product Development Engineer who can operate across both new product development and manufacturing engineering activities - someone comfortable working closely with R&D while also driving process development, scalability, and commercialization efforts.
This is a highly visible role within a collaborative environment where engineering has a direct impact on product success and patient outcomes.
Key responsibilities include:
Supporting development and transfer of Class III medical devices into manufacturing
Process development, validation, and continuous improvement initiatives
Design for manufacturability (DFM) and engineering change activities
Cross-functional collaboration with R&D, Quality, Regulatory, and Operations
Root cause investigations, troubleshooting, and CAPA support
Developing manufacturing documentation, work instructions, and test methods
Supporting verification/validation and product scale-up activities
Ideal background:
3+ years of engineering experience within medical devices
Experience supporting Class III products preferred
Exposure to product development and manufacturing engineering environments
Strong understanding of GMP/FDA regulated environments
Hands-on mindset with strong problem-solving capabilities
Experience with process validation, NPI, or sustaining engineering activities is a plus
The company offers strong technical exposure, exciting technology, and the chance to work on products making a real impact in the market.
If you’d be interested in hearing more, feel free to message me directly.
Show more Show less