Program Manager

Integer

8-10 years project management experience
Medical device manufacturing environment
Product and equipment transfer leadership
Lead process transfer activities from sending sites to the receiving site ensuring minimal disruption and excellent quality assurance

Job Summary

  • Lead process transfer activities from sending sites to the receiving site ensuring minimal disruption and excellent quality assurance.
  • Ensure all transfer deliverables satisfy ISO 13485 and FDA 21 CFR 820 regulatory requirements while driving operational readiness.
  • Act as the primary point of contact for internal and external stakeholders including suppliers, contractors, and regulatory bodies.

Matching Summary

Lead process transfer activities from sending sites to the receiving site ensuring minimal disruption and excellent quality assurance.

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 in medical device project management
  • Proficiency with MS Project or Smartsheet
  • Knowledge of GMP and regulatory compliance

Work Rights

Not specified

Tailored Resume

Cover Letter