Project Manager - Medical Device Manufacturing Transfer
Technology
Job Description
Job Title: Project Manager – Medical Device Manufacturing Transfer
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Location: Arvada, CO (Onsite)
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Experience: 12+ years in Project/Program Management, including 5+ years in Medical Devices
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Job Description
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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.
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Key Responsibilities
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- 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.
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Required Qualifications
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- 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.
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Preferred Qualifications
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- PMP certification.
- Experience with Lean Manufacturing and Six Sigma methodologies.
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