Manufacturing Program Manager

Position Summary

We are seeking an experienced and results-driven Sustaining Project Manager to lead post-launch product support and sustaining initiatives within a regulated medical device manufacturing environment. The successful candidate will manage cross-functional projects focused on product lifecycle management, manufacturing optimization, process improvements, and continuous operational excellence.

This role requires strong project management expertise, experience in Original Equipment Manufacturing (OEM), and a proven track record of improving manufacturing performance through line efficiency enhancement, downtime reduction, and scrap management. The candidate will collaborate closely with Engineering, Manufacturing, Quality, Supply Chain, and Regulatory Affairs teams to ensure product quality, regulatory compliance, and successful project execution.

Key Responsibilities

• Lead and manage sustaining and post-launch projects for medical device products throughout their lifecycle.
• Coordinate cross-functional teams including Engineering, Manufacturing, Quality, Supply Chain, Regulatory Affairs, and Operations.
• Drive product enhancements, manufacturing process improvements, cost-reduction initiatives, and operational efficiency projects.
• Develop and maintain project plans, schedules, budgets, risk assessments, and project documentation.
• Monitor project progress, identify risks, and implement mitigation strategies to ensure successful project delivery.
• Support engineering change control processes, design changes, and product updates.
• Analyze manufacturing performance metrics and implement initiatives to improve line efficiency and productivity.
• Lead efforts focused on downtime reduction, scrap reduction, yield improvement, and overall manufacturing optimization.
• Ensure compliance with FDA regulations, GMP requirements, quality standards, and internal quality management systems.
• Facilitate stakeholder communication and provide regular project status updates to leadership teams.
• Support root cause investigations, corrective actions, and continuous improvement initiatives.
• Collaborate with OEM partners, suppliers, and internal teams to resolve product and manufacturing-related issues.

Required Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Manufacturing, or a related technical discipline.
• 6–8 years of project management experience within a manufacturing environment.
• Minimum 5 years of experience in medical device manufacturing or other highly regulated industries.
• Experience supporting product launch, sustaining engineering, and lifecycle management activities.
• Hands-on experience working within an Original Equipment Manufacturing (OEM) environment.
• Strong understanding of manufacturing operations, production processes, and quality systems.
• Demonstrated success in improving line efficiency, reducing downtime, and managing scrap reduction initiatives.
• Experience with project management methodologies, tools, and best practices.
• Knowledge of FDA regulations, GMP requirements, and medical device quality standards.
• Excellent leadership, communication, stakeholder management, and organizational skills.
• Ability to manage multiple projects simultaneously in a fast-paced environment.

Preferred Qualifications

• PMP (Project Management Professional) certification or equivalent project management certification.
• Experience with Lean Manufacturing, Six Sigma, Kaizen, or Continuous Improvement methodologies.
• Familiarity with CAPA, risk management, validation processes, and change control systems.
• Experience working with ERP and project management software tools.

Key Competencies

• Project Planning & Execution
• Cross-Functional Team Leadership
• Manufacturing Operations Management
• Sustaining Engineering
• Product Lifecycle Management
• Continuous Improvement
• Risk Management
• Regulatory Compliance
• Process Optimization
• Stakeholder Communication
• Problem Solving & Decision Making

Success Metrics

• On-time and on-budget project delivery
• Improvement in manufacturing line efficiency
• Reduction in production downtime and scrap rates
• Successful implementation of product and process changes
• Compliance with quality and regulatory requirements
• Effective stakeholder satisfaction and communication