What are the responsibilities and job description for the Project Manager – Medical Device Manufacturing Transfer position at Apetan Consulting LLC?
Job Title: Project Manager – Medical Device Manufacturing Transfer
Location: Arvada, CO (Onsite)
Experience: 12 years in Project/Program Management, including 5 years in Medical Devices
Job Description
We are seeking an experienced Project Manager to lead medical device manufacturing transfer projects. The ideal candidate will manage cross-functional teams and ensure successful manufacturing transfers while maintaining regulatory compliance, product quality, and supply continuity.
Key Responsibilities
- Lead end-to-end medical device manufacturing transfer projects.
- Manage cross-functional teams across engineering, quality, regulatory, manufacturing, and supply chain.
- Oversee Bills of Materials (BOMs), process documentation, and manufacturing readiness.
- Manage process validation activities, including IQ/OQ/PQ.
- Ensure compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR, and GMP requirements.
- Identify and manage project risks, budgets, schedules, and resources.
- Ensure continuity of supply during manufacturing transfers.
- Provide regular project updates and executive-level reports.
- Coordinate quality, regulatory, and risk management activities throughout the transfer process.
Required Qualifications
- 12 years of project/program management experience.
- 5 years of experience in the medical device industry.
- Strong experience managing medical device manufacturing transfers.
- Knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, and GMP.
- Experience with process validation, IQ/OQ/PQ, and risk management.
- Proficiency in Microsoft Project.
- Strong leadership, communication, planning, and stakeholder management skills.
- Experience with sterile disposable medical devices is preferred.
Preferred Qualifications
- PMP certification.
- Experience with Lean Manufacturing and Six Sigma methodologies.