What are the responsibilities and job description for the Product Development Engineer position at ACE Partners?
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.