This job is closed
We regret to inform you that the job you were interested in has been closed. Although this specific position is no longer available, we encourage you to continue exploring other opportunities on our job board.
Actalent - Fremont, CA
posted 2 months ago
Full-time - Mid Level
Fremont, CA
10,001+ employees
Administrative and Support Services
About the position
The Manufacturing Process Engineer will play a crucial role in supporting new product introduction (NPI) lines and enhancing existing product lines within a medical device manufacturing environment. This position involves developing and validating manufacturing processes for new products, implementing cost-effective improvements for current lines, and ensuring compliance with medical regulations through proper documentation.
Responsibilities
- Support manufacturing of NPI lines.
- Develop the manufacturing and validation process for new products.
- Design the validation and qualification of manufacturing equipment and process changes.
- Work on existing lines to implement process improvements for cost-effective changes.
- Document changes within compliance for FDA and ISO regulations.
- Update BOM in accordance with regulatory requirements.
Requirements
- Troubleshooting skills
- Design for manufacturing expertise
- Process development experience
- Manufacturing engineering knowledge
- Strong documentation skills
- Validation experience
- Familiarity with medical devices
- Experience with BOM
- Knowledge of IQ, OQ, PQ processes
- Analytical problem-solving skills
- Proficiency in SolidWorks
- Understanding of Six Sigma principles
- Experience with Lean manufacturing
Nice-to-haves
- Experience with Class III medical devices or contract manufacturing
