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Merck logo

Senior Engineer, Device Technical Operations (Hybrid)

Merck · Multiple locations

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OtherFull-time$117k–$184kCompany career page

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What they're looking for

  • Bachelor's degree in mechanical, biomedical, chemical, or materials engineering
  • Minimum 5 years pharmaceutical, biologic, or medical device engineering experience
  • At least 2 years supporting commercial manufacturing operations
  • Expertise in design controls, risk analysis, design verification testing, and process validation
  • Technical experience in injection molding, automation, complex assembly and packaging
  • Strong knowledge of ISO 13485, ISO 14971, and quality management systems
  • Direct experience with autoinjectors, ophthalmic, or inhalation products preferred

What you'll be doing

  • Apply design controls, design transfer, risk management, and verification testing to develop medical device solutions
  • Support internal and external component and combination product manufacturing globally
  • Identify manufacturing issues, perform root cause analysis, and provide technical solutions
  • Develop strategic technology transfer plans and lead cross-functional teams through late-stage development
  • Support regulatory inspections, pre-approval activities, and ensure compliance with quality standards

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