Senior Biomedical Process Engineer

1 day ago


Somerville, United States Astrix Full time

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:

  • Degree in Chemical Engineering, Bio-engineering, other related discipline
  • 3+ years of industry experience within Process Engineering
  • Understanding of Medical Devices Design Controls is required.
  • Familiarity with statistical analysis and design of experiments



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