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

Job Title: Project Manager – Medical Device Manufacturing Transfer

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.