Not specified (assumed to be hybrid based on typical industry practices).
8-10 years project management experience
Medical device manufacturing environment
Product and equipment transfer leadership
The Integer Group is seeking a Program Manager with extensive experience in project management within the medical device manufacturing sector. The role involves leading product transfer activities, ensuring compliance with regulatory standards, and engaging with various stakeholders to drive projects to successful completion
Job Summary
Lead process transfer activities from sending sites to receiving sites ensuring minimal disruption and excellent quality assurance.
Ensure all transfer deliverables satisfy ISO 13485 and FDA 21 CFR 820 regulatory requirements.
Act as the primary point of contact for internal and external stakeholders including suppliers, contractors, and regulatory bodies.
Matching Summary
Match Score: 85
The Integer Group is seeking a Program Manager with extensive experience in project management within the medical device manufacturing sector. The role involves leading product transfer activities, ensuring compliance with regulatory standards, and engaging with various stakeholders to drive projects to successful completion.
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 and IQ/OQ/PQ protocols
Cross-functional stakeholder management
Nice-to-have
Lean Six Sigma credentials
PMP or Prince2 certification
Strong coaching abilities
International travel up to 60%
Experience with cleanroom operations
Conflict resolution skills
Key Requirements
Bachelor's degree in engineering or Project Management