Staff Medical Device Autoinjector Engineer

Lifelancer
Greenville, NC
Category Engineering
Job Description
The Staff Medical Device Autoinjector Engineer will be responsible for developing and maintaining Standard Operating Procedures (SOPs), On-the-Job Training (OJT) documents, and line templates, and ensuring compliance with regulatory standards, optimizing manufacturing processes, and collaborating with vendors.

Requirements

  • Graduate level degree in Pharmaceutical Engineering, Chemical Engineering, Physics, or similar field highly preferred.
  • 8+ years of operations experience in a pharmaceutical manufacturing environment.
  • Experience working with Device vendors and OEMS
  • Strong experience working with Autoinjectors
  • Knowledge of the regulatory requirements for devices and combination products with the US and EU
  • Experience of managing Device Development Projects, ideally from concept to launch
  • Understanding of device and drug/device combination regulatory requirements
  • Experience with process improvement methodologies (e.g., Lean, Six Sigma).

Benefits

  • Competitive salary
  • Annual incentive bonus plan
  • 401K with company match up to 6%
  • Tuition reimbursement
  • Other employee benefits
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