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Process Development Engineer

Job in Rochester, Olmsted County, Minnesota, 55905, USA
Listing for: United Pharma
Full Time position
Listed on 2026-06-03
Job specializations:
  • Engineering
    Manufacturing Engineer, Quality Engineering
Salary/Wage Range or Industry Benchmark: 80000 - 100000 USD Yearly USD 80000.00 100000.00 YEAR
Job Description & How to Apply Below

We are seeking a Process Development Engineer to support manufacturing development, validation, and process optimization activities for Class III medical devices. This role will work closely with QA, R&D, and Production teams to improve manufacturing processes and support new technology integration.

Responsibilities
  • Develop validation protocols and manufacturing documentation
  • Support automation and fixture improvements to reduce manual processes
  • Ensure compliance with GMP & ISO 13485 requirements
  • Collaborate with cross‑functional teams to support process scale‑up and production readiness
Qualifications
  • 5–8+ years of Process Development or Manufacturing Engineering experience
  • Medical device industry experience (Class III preferred)
  • Experience with IQ/OQ/PQ, TMV & process documentation
  • Knowledge of GMP & ISO 13485 standards
  • Strong troubleshooting and communication skills
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