Project Manager

Engineering Project Manager (Medical Device Manufacturing / NPI)

Job Description

We are seeking an Engineering Project Manager to lead new product introduction (NPI) and manufacturing-driven projects within a medical device environment. This individual will be responsible for managing projects from initiation through production handoff, ensuring alignment across engineering, quality, manufacturing, and customer stakeholders.

This role is highly cross-functional and requires oversight—not hands-on execution—of design, quality, and manufacturing activities. The Engineering Project Manager will work closely with internal teams across multiple facilities, coordinating efforts to deliver projects on time, within scope, and aligned with quality and cost expectations.

The ideal candidate will come from a medical device manufacturing background and have transitioned into project management, bringing both technical understanding and strong leadership capabilities. This position requires a high level of organization, communication, and the ability to operate effectively in a fast-paced, multi-site environment.

Day-to-Day

• Lead and manage NPI projects from kickoff through production handoff
• Serve as the primary point of contact between customers and internal project teams
• Coordinate cross-functional teams including Manufacturing Engineering, Quality Engineering, Design, Automation, and Operations
• Develop and maintain detailed project plans, timelines, and deliverables across multiple concurrent projects
• Oversee project execution across multiple manufacturing sites, ensuring alignment and communication
• Identify and mitigate project risks throughout all phases of development
• Support technical problem-solving efforts in collaboration with engineering teams
• Monitor project performance related to scope, cost, timeline, and quality
• Partner with suppliers and external vendors for tooling, equipment, and process development
• Oversee technical documentation including validation protocols (IQ/OQ/PQ) and project deliverables
• Facilitate meetings, track action items, and ensure accountability across stakeholders
• Drive process improvements during NPI to optimize cost, efficiency, and product quality

Requirements / Qualifications

• 5–15 years of experience in engineering or project management within a medical device manufacturing environment
• Strong experience leading cross-functional projects, particularly in NPI or manufacturing-driven programs
• Background in engineering disciplines related to manufacturing (tooling, machining, molding, assembly, etc.)
• Experience overseeing design, quality, and manufacturing teams (not hands-on design ownership)
• Familiarity with 3D CAD environments (SolidWorks, Creo, or similar) for oversight purposes
• Strong understanding of manufacturing processes such as injection molding, machining, assembly, or tooling
• Experience managing projects across multiple locations or sites
• Strong project planning and execution skills (Smartsheet or similar tools preferred)
• Ability to interpret technical drawings, specifications, and engineering documentation
• Experience with validation activities (IQ/OQ/PQ) and regulated environments
• Knowledge of FDA-regulated environments and ISO standards (ISO 13485 preferred)
• Strong communication skills with ability to interface with customers and cross-functional teams
• Ability to manage multiple priorities in a fast-paced environment