Senior Project Manager – Medical Device Manufacturing Transfer

Apetan Consulting LLC; Arvada (CO); On-site; USD 150,000 - 190,000; Full time

Job summary

Apetan Consulting LLC is seeking an experienced Project Manager to lead medical device manufacturing transfer projects. The role requires coordinating cross-functional teams across engineering, quality, regulatory, manufacturing, and supply chain to ensure timely, compliant transfers and continuity of supply.

The ideal candidate has 12+ years in project/program management, 5+ years in medical devices, and knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, and GMP.

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.
• Experience with sterile disposable medical devices is preferred.

Responsibilities

• Lead end-to-end medical device manufacturing transfer projects.
• Manage cross-functional teams across engineering, quality, regulatory, manufacturing, and supply chain.
• Oversee 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.

Skills

Project management

Program management

Cross-functional leadership

Regulatory compliance

Risk management

Stakeholder management

Communication

Leadership

Education

PMP certification

Tools

Microsoft Project

Job description

Apetan Consulting LLC is seeking an experienced Project Manager to lead medical device manufacturing transfer projects. The role requires coordinating cross-functional teams across engineering, quality, regulatory, manufacturing, and supply chain to ensure timely, compliant transfers and continuity of supply.

The ideal candidate has 12+ years in project/program management, 5+ years in medical devices, and knowledge of ISO 13485, FDA 21 CFR Part 820, EU MDR, and GMP.