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Project Manager - Medical Device Manufacturing

The Opportunity

We are looking for an experienced Project Manager to lead high-impact projects within a regulated medical device manufacturing environment. In this role, you’ll bring together Operations, Engineering, Quality, Regulatory Affairs, Supply Chain, R&D, Finance, and external partners to turn complex manufacturing initiatives into successful, sustainable results.

You’ll manage projects from initial concept through implementation and closeout, with responsibility for scope, schedule, budget, risk, quality, and stakeholder alignment. Projects may include technology transfers, process validation, equipment installations and qualification, automation, facility upgrades, cost reduction, and capacity expansion.

This is a great opportunity for someone who enjoys working at the intersection of project leadership, manufacturing, engineering, and quality and knows how to move projects forward without compromising safety or compliance.

What You’ll Do

• Lead cross-functional manufacturing projects from charter and planning through execution, implementation, and closeout.
• Develop project scope, schedules, resource plans, budgets, milestones, and deliverables.
• Drive projects involving new product introduction, design and technology transfer, process validation, equipment qualification, automation, facility improvements, and capacity expansion.
• Monitor project schedules and critical paths, proactively addressing issues that could impact safety, quality, delivery, cost, or compliance.
• Identify and manage project risks, issues, assumptions, and dependencies while escalating critical decisions when needed.
• Coordinate manufacturing readiness, including validation strategies, training, documentation, material availability, and production ramp-up.
• Partner closely with Quality and Regulatory teams to ensure compliance with cGMP, ISO 13485, applicable FDA requirements, change-control processes, validation requirements, and internal procedures.
• Lead project governance and phase-review meetings, establish accountability, and drive timely decision-making.
• Manage project financials, including capital requests, forecasts, purchase commitments, cost tracking, and variances.
• Partner with suppliers, contractors, and equipment vendors to ensure deliverables meet quality, schedule, and commercial expectations.
• Provide clear, concise updates to project sponsors and senior leaders regarding progress, risks, decisions, and resource needs.
• Capture lessons learned and help strengthen project-management practices across the manufacturing organization.

What You’ll Bring

Required Qualifications

• Bachelor’s degree in Engineering, Operations, Life Sciences, Business, or a related field.
• 5+ years of experience in project management, engineering, operations, or manufacturing.
• At least 3 years of experience within a regulated medical device, pharmaceutical, biotechnology, or similarly controlled manufacturing environment.
• Demonstrated success leading cross-functional projects with accountability for schedule, budget, risk management, and leadership communication.
• Working knowledge of quality systems, change control, validation, risk management, and controlled documentation.
• Strong communication, facilitation, problem-solving, and organizational skills.
• Proficiency with project scheduling, presentation, spreadsheet, and collaboration tools.

Preferred Qualifications

• PMP or equivalent project-management certification.
• Experience with design transfer, process validation, equipment qualification, or manufacturing-site expansion.
• Lean, Six Sigma, or structured problem-solving experience.
• Experience with ERP, PLM, QMS, or project portfolio management systems.
• Experience leading capital projects and managing third-party suppliers or contractors.

What Success Looks Like

You’ll be successful in this role by delivering projects safely, compliantly, on time, and within budget while building strong alignment across technical and business teams. Your work will translate into measurable manufacturing outcomes such as increased capacity, improved yield and reliability, shorter cycle times, lower costs, and stronger operational performance.

Most importantly, you’ll ensure that projects don’t simply cross the finish line. They are handed off sustainably, with trained teams, controlled documentation, completed validation requirements, and clear long-term ownership.

Why This Role Stands Out

This isn’t a project-management role where you’ll simply maintain timelines and status reports. You’ll be directly involved in how products, processes, equipment, and manufacturing operations come together, working with cross-functional teams to solve problems and deliver meaningful improvements in a highly regulated environment.

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