Program Manager

SoundHire

8-10 years project management experience
Medical device manufacturing environment
Product/process/equipment transfer leadership
Lead the integrated Master Transfer Plan spanning sending and receiving sites to ensure minimal disruption and excellent quality assurance

Job Summary

  • Lead the integrated Master Transfer Plan spanning sending and receiving sites to ensure minimal disruption and excellent quality assurance.
  • Ensure all transfer deliverables satisfy strict 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 the integrated Master Transfer Plan spanning sending and receiving sites to ensure minimal disruption and excellent quality assurance.

Skills & Requirements

Must-have

  • 8-10 years project management experience
  • Medical device manufacturing environment
  • Product/process/equipment transfer leadership
  • ISO 13485 and FDA 21 CFR 820 compliance
  • Master Transfer Plan development and execution
  • Equipment validation IQ/OQ/PQ protocols
  • Cross-functional stakeholder management

Nice-to-have

  • PMP or Prince2 certification preferred
  • Lean Six Sigma credentials
  • Strong coaching and conflict resolution skills
  • Experience with EU/US logistics and import clearance
  • Leadership in Quality, RA, or Supply Chain

Key Requirements

  • Bachelor's degree in engineering or Project Management (Master's preferred)
  • Minimum 8-10 years of experience in medical device manufacturing
  • Proven track record in NPI to production transitions
  • Strong knowledge of GMP, EHS, and regulatory compliance
  • Ability to travel internationally up to 60%

Work Rights

Not specified

Tailored Resume

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