Project Manager - MedTech Product /NPI

Job Title: Project Manager - MedTech Product / NPI

Location: Kalamazoo, Michigan

Duration: 24+ Months with extension

Job Summary

The Project Manager at client leads complex manufacturing projects within regulated MedTech environments, with a primary focus on new product implementations, product transfers, manufacturing readiness, and sustaining production initiatives. This role is responsible for coordinating cross-functional teams and driving projects from planning and development through manufacturing implementation, validation, and production launch.

The Project Manager serves as a key liaison between engineering, manufacturing, quality, operations, supply chain, regulatory, and customer stakeholders to ensure projects are delivered on time, within scope, and in accordance with quality and regulatory requirements.

This position requires a strong understanding of project management principles, excellent organizational and communication skills, and the ability to effectively lead technical teams through complex product and manufacturing initiatives.

Responsibilities:

• Lead end-to-end MedTech product transfer and new product implementation projects from initial planning through manufacturing launch and production stabilization.

• Develop and maintain project plans, schedules, milestones, resource requirements, budgets, and project deliverables.

• Coordinate cross-functional activities across engineering, manufacturing, quality, regulatory, operations, supply chain, sourcing, and external suppliers.

• Manage product transfers from development or existing manufacturing locations into new manufacturing environments, ensuring technical, operational, and quality requirements are addressed.

• Lead New Product Introduction (NPI/NPD) activities, including manufacturing readiness, process development, tooling, equipment, documentation, training, and production launch.

• Establish project timelines and identify critical path activities, dependencies, risks, and resource constraints.

• Facilitate project meetings, drive action items, and maintain clear communication with internal teams and customer stakeholders.

• Track project progress against milestones and proactively identify and resolve issues that could impact schedule, cost, quality, or scope.

• Coordinate engineering and manufacturing deliverables including drawings, specifications, BOMs, work instructions, manufacturing processes, equipment requirements, and other controlled documentation.

• Support Engineering Change Orders (ECOs), Manufacturing Change Orders (MCOs), deviations, CAPAs, and other controlled change activities as they relate to product implementation and manufacturing.

• Partner with Quality and Regulatory teams to ensure projects comply with applicable FDA, ISO 13485, design control, risk management, and quality system requirements.

• Coordinate supplier and contract manufacturer activities associated with product transfers, component sourcing, tooling, equipment, and manufacturing readiness.

• Support production builds, pilot runs, process validation, equipment qualification, and manufacturing process implementation as required.

• Identify project risks and develop mitigation and contingency plans to maintain project objectives.

• Prepare project status reports, dashboards, presentations, and executive-level updates for customers and internal leadership.

• Manage multiple projects and competing priorities while maintaining strong attention to detail and accountability for deliverables.

• Identify opportunities for process improvement and drive continuous improvement within project execution and manufacturing implementation activities.

Requirements:

• Bachelor’s degree in Engineering or another technical discipline preferred.

• 5+ years of project management experience, preferably within the Medical Device, MedTech, Manufacturing, or other highly regulated industry.

• Experience leading product transfers, manufacturing transfers, New Product Introduction (NPI), New Product Development (NPD), or manufacturing implementation projects.

• Strong understanding of manufacturing processes, product development, and the transition of products from engineering/development into production.

• Demonstrated ability to lead cross-functional technical teams and manage projects involving multiple stakeholders and functional organizations.

• Strong project planning and execution skills, including experience managing schedules, milestones, dependencies, risks, resources, and deliverables.

• Experience working within regulated environments with familiarity with FDA regulations, ISO 13485, design controls, change control, and quality systems.

• Strong written and verbal communication skills, with the ability to communicate effectively with engineers, manufacturing personnel, quality teams, customers, suppliers, and executive leadership.

• Proficiency with project management tools and Microsoft Office, including Excel, PowerPoint, and project scheduling/tracking tools.

• Ability to work independently, prioritize competing demands, and drive accountability across cross-functional teams.

Preferred:

• PMP certification strongly preferred.

• Technical background in Mechanical, Electrical, Manufacturing, Industrial, Systems, or Software Engineering.

• Experience with medical device product transfers and manufacturing site transfers.

• Experience with process validation, equipment qualification, tooling, production builds, and manufacturing readiness.

• Experience working with contract manufacturers, suppliers, or external manufacturing partners.

• Familiarity with ERP, PLM, or quality management systems used in regulated manufacturing environments.