Program Manager

The Integer Group

**
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 with extensive experience in project management, particularly within the medical device manufacturing sector. The role involves leading product/process transfers, ensuring compliance with industry standards, and engaging with various stakeholders while fostering a collaborative and inclusive work environment. **

Job Summary

  • The role requires leading integrated product transfers from sending sites to receiving locations while ensuring minimal disruption and high quality.
  • Candidates must ensure all transfer deliverables satisfy strict ISO 13485 and FDA 21 CFR 820 regulatory requirements.
  • Success is measured by completing operational ramp-ups within agreed timelines, achieving cost-saving targets, and maintaining zero major non-conformances during audits.

Matching Summary

Match Score: 75

** The Integer Group is seeking a Program Manager with extensive experience in project management, particularly within the medical device manufacturing sector. The role involves leading product/process transfers, ensuring compliance with industry standards, and engaging with various stakeholders while fostering a collaborative and inclusive work environment. **

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

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 managing NPI to production transitions
  • Proficiency with PM tools like MS Project or Smartsheet

Work Rights

Not specified

Tailored Resume

Cover Letter