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Process Development Engineer II
2 months ago
Silk Road Medical, Inc. is a medical device company dedicated to reducing the risk of stroke. We're seeking a skilled Process Development Engineer II to contribute to our cross-functional NPD project teams.
Key Responsibilities- Collaborate with senior engineers to develop manufacturing processes, PFMEA, and pilot/qualification builds.
- Design and perform process characterization and development activities, including screening experiments, DOE, and process mapping.
- Design and qualify process tooling, fixtures, and equipment, with varying degrees of semi-automation.
- Develop manufacturing documentation, including SOPs and records.
- Contribute to PFMEA activities and perform job safety risk assessments.
- Lead aspects of manufacturing pilot builds and IQ, OQ, PQ.
- Bachelor's degree in Engineering or related field.
- 2+ years of process development experience in a manufacturing environment, with medical device experience preferred.
We provide a comprehensive benefits package, including robust and affordable benefits for employees and their dependents. Our commitment to diversity, equity, and inclusion ensures a welcoming environment for all employees.
