Program Manager

The Integer Group

Not specified
8-10 years project management experience
Medical device manufacturing environment
Product and equipment transfer leadership
The Integer Group is seeking a Program Manager with extensive experience in project management within the medical device manufacturing sector. The ideal candidate will lead product transfers and ramp-up activities, ensuring compliance with industry regulations while fostering collaboration and stakeholder engagement

Job Summary

  • The role requires building and managing an integrated Master Transfer Plan spanning sending and receiving sites while ensuring alignment with corporate strategy.
  • Candidates must lead process transfer activities, including equipment de-installation, validation protocols, and operational readiness to meet ISO 13485 and FDA requirements.
  • Success is measured by completing product transfers within budget, achieving zero major non-conformances during audits, and maintaining effective stakeholder communication.

Matching Summary

Match Score: 85

The Integer Group is seeking a Program Manager with extensive experience in project management within the medical device manufacturing sector. The ideal candidate will lead product transfers and ramp-up activities, ensuring compliance with industry regulations while fostering collaboration and stakeholder engagement.

Skills & Requirements

Must-have

  • 8-10 years project management experience
  • Medical device manufacturing environment
  • Product and equipment transfer leadership
  • ISO 13485 and FDA 21 CFR 820 compliance
  • Process validation strategy execution
  • Cross-functional stakeholder management

Nice-to-have

  • Lean Six Sigma credentials
  • PMP or Prince2 certification
  • Strong coaching and conflict resolution skills
  • International travel capability up to 60%
  • Experience with cleanroom and EHS readiness

Key Requirements

  • Bachelor's degree in engineering or Project Management
  • Master's degree preferred
  • Minimum 8-10 years of relevant experience
  • Proficiency with MS Project or Smartsheet
  • Knowledge of GMP and regulatory compliance

Work Rights

Not specified

Tailored Resume

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