Program Manager

The Integer Group

**
8-10 years project management experience
Medical device manufacturing environment
Product and equipment transfer leadership
** The Integer Group seeks a Program Manager with extensive experience in project management within the medical device manufacturing sector. The role involves leading product transfers, ensuring compliance with industry regulations, and engaging with stakeholders to drive operational readiness. **

Job Summary

  • The role requires leading integrated Master Transfer Plans spanning sending and receiving sites while ensuring alignment with corporate strategy.
  • Candidates must drive operational readiness including equipment installation, validation, and workforce onboarding to satisfy 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: 75

** The Integer Group seeks a Program Manager with extensive experience in project management within the medical device manufacturing sector. The role involves leading product transfers, ensuring compliance with industry regulations, and engaging with stakeholders to drive operational readiness. **

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 IQ OQ PQ protocols
  • Cross-functional stakeholder management
  • International travel up to 60%

Nice-to-have

  • PMP or Prince2 certification preferred
  • Lean Six Sigma credentials
  • Strong coaching and conflict resolution skills
  • Experience with cleanroom and EHS readiness
  • Background in Quality, RA, or Supply Chain

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

Cover Letter