Sr Process Engineer

1 month ago


Lafayette, United States Planet Pharma Full time

613505


Our client, a leading Medical Device company in Lafayette, CO, is looking for a Sr. Process Engineer to support a lead manufacturing engineer during development and validation of a new production lines for a new medical device


Required Skills:

  • Minimum 4 years of experience required with a Bachelor's Degree, or Minimum 2 years of experience with an advanced degree.
  • Process Validation
  • Gauge R&R
  • Design of Experiments
  • Test Method Validation


Responsibilities:

  • Support development and validation for new production processes.
  • Develop and characterize the manufacturing process window and secure process capability across all variation in production materials and processes.
  • Develop and execute plans, including statistical analysis, to evaluate process repeatability through equipment qualification and process validation (IQ/OQ/PQ).
  • Define and generate all required documentation in support of manufacturing protocols, reports, changes, and manufacturing instructions. These include Engineering protocols, reports, process risk documents (PFMEA), manufacturing instructions, change orders and statistical analysis.
  • Provide engineering support to manufacturing operations and address quality issues arising on the production floor.



***Compensation within this range will be commensurate with level of experience***


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