Device Engineering Manager

5 days ago


Stockholm, Stockholm, Sweden PharmaRelations ApS Full time
Job Description

Nordberg Medical seeks a Senior Production Process Engineer to drive manufacturing process development, optimization, and validation for implantable Class III medical devices.

Key Responsibilities:
  • Collaborate with cross-functional teams on production development, technology transfer, and implementation of efficient, scalable, and compliant production processes.
  • Develop and maintain process workflows, control plans, and standard operating procedures (SOPs).
Process Validation and Qualification:
  • Conduct process validation activities, including IQ/OQ/PQ, for new and modified manufacturing processes.
  • Ensure validation protocols align with regulatory standards (e.g., GMP, ISO 13485, and FDA 21 CFR Part 820) and execute effectively to meet quality requirements.


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