Sr. Manufacturing Process Engineer - Medical Device

Planet Pharma
Boulder, CO

Job ID: 628425


Our client, a leading Medical Device company, is seeking an experienced Sr. Process Manufacturing Engineer for its Boulder location. See below for other details!


Top Skills Needed:

1. Demonstrated experience in validations IQ, OQ, PQ

2. Demonstrated experience with running medium to large capital projects

3. Experience with statistical methods

Responsibilities:

  • Provide engineering support for our electron beam manufacturing line ensuring optimal operation, performance, and adherence to policy.
  • Manage changing priorities and respond quickly to challenges in a fast-paced, dynamic manufacturing environment.
  • Design, develop, and improve manufacturing processes, procedures, and production layouts for product assembly, equipment installation, and material handling.
  • Work closely with R&D, Quality, and other cross-functional teams to drive the integration of new technologies, process changes, and continuous improvements.
  • Validate new components, systems, and process changes to ensure product performance, quality, and efficiency.
  • Inspects performance of machinery, equipment, and tools to verify their efficiency, and investigates and initiates corrective action of problems and deficiencies to ensure product quality.
  • Adapts machine or equipment design to factory and production conditions.
  • Ensure all manufacturing processes, equipment, and procedures comply with industry regulations and standards, with a focus on maintaining safety and product integrity.
  • Mentor and coach junior engineers and team members, providing guidance in design, troubleshooting, and process optimization.


Required Knowledge and Experience:

  • Bachelor's Degree within an Engineering realm and 4+ years of experience
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