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Senior Full Stack Software Engineer
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Senior Process Engineer
1 month ago
Summary:
- Support and lead portions of Component Qualification process
- Lead, plan and execute process development activities from protocol generation through data analysis
- Support Process Validation activities for Clinical Trial Manufacturing readiness.
- Collaborate cross-functionally to design develop or improve and implement new manufacturing processes for clinical trial manufacturing enhancement.
- Support test method development and validation
- CTQ (Critical-to Quality) Cascade
- Lead DFM/A (Design for Manufacturing & Assembly) efforts for new commercial medical device
- Interact with external equipment vendors to procure equipment for commercial medical device manufacturing process
Qualifications:
- PhD in Chemical Engineering, Bio-engineering, other related discipline
- Understanding of Medical Devices Design Controls is required.
- Familiarity with statistical analysis and design of experiments
