Program Manager

The Integer Group

Not specified
8-10 years project management experience
Product and equipment transfer leadership
Iso 13485 and fda 21 cfr 820 compliance
The Integer Group is seeking a Program Manager to lead cross-functional project initiatives, focusing on product transfers within the medical device manufacturing sector. The ideal candidate should have extensive project management experience, particularly in compliance with regulatory standards, and demonstrate strong leadership and communication skills

Job Summary

  • The role involves building and managing an integrated Master Transfer Plan spanning sending and receiving sites for medical device manufacturing.
  • Candidates must ensure all transfer deliverables satisfy ISO 13485 and FDA 21 CFR 820 regulatory requirements while leading validation protocols.
  • Success is measured by completing product transfers within agreed timelines, achieving zero major non-conformances during audits, and meeting cost-saving targets.

Matching Summary

Match Score: 85

The Integer Group is seeking a Program Manager to lead cross-functional project initiatives, focusing on product transfers within the medical device manufacturing sector. The ideal candidate should have extensive project management experience, particularly in compliance with regulatory standards, and demonstrate strong leadership and communication skills.

Skills & Requirements

Must-have

  • 8-10 years project management experience
  • Product and equipment transfer leadership
  • ISO 13485 and FDA 21 CFR 820 compliance
  • Master Transfer Plan development and execution
  • Cross-functional stakeholder management

Nice-to-have

  • Lean Six Sigma credentials preferred
  • 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 preferred)
  • Minimum 8–10 years of experience in medical device manufacturing
  • Proven track record in NPI to production transitions
  • Proficiency with PM tools like MS Project or Smartsheet

Work Rights

Not specified

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