Completes Design History File documentation ,Creates and delivers presentations throughout the organization,Design of Experiments (DOE) and Statistical Process Control (SPC),Develops plans to evaluate process repeatability and stability ,Develops product and process improvements,Participates in procedure writing and review ,Performs deliverable checklist audits ,Performs process and equipment validations ,Provides technical support to other engineers ,Utilizes FMEA within process development ,Ensures compliance with GMP’s,Generates documentation for engineering protocols and reports ,Writes engineering and manufacturing specifications
• Experience with Risk Analysis is a key requirement for this position.
• Experience in medical device or other regulated industry such as aerospace or pharmaceuticals desired.
Entegee - 21 months ago
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