Senior Manufacturing Project Manager (Medical Device)

Job Title: EU MDR Manufacturing Site Lead / Project Manager (Spine)

Location: Warsaw, IN

Industry: Medical Device

Overview

We are seeking an experienced EU MDR Manufacturing Site Lead / Project Manager to drive site-level execution of EU MDR implementation activities for a leading medical device manufacturer. This role will act as the primary liaison between the global program team and site leadership, ensuring all regulatory deliverables are completed on time, within scope, and in compliance.

Key Responsibilities

• Lead all EU MDR implementation activities at the assigned manufacturing site
• Own and execute site-level project plans aligned with global MDR timelines
• Serve as the primary point of contact between program leadership and site teams
• Coordinate cross-functional efforts across Manufacturing, Quality, Engineering, and Supply Chain
• Drive execution of engineering and manufacturing changes (ECO/MCO/SMECO) and documentation updates
• Track milestones, identify risks, and implement mitigation plans to maintain timelines
• Escalate critical risks, constraints, or delays to program leadership
• Ensure audit readiness and compliance through proper documentation and traceability
• Support manufacturing operations including process improvements, master data management, and shop floor execution
• Maintain and improve manufacturing process documentation, labor standards, and product quality

Qualifications

• Bachelor’s degree in Engineering (required)
• 7+ years of experience in manufacturing, engineering, or operations within a regulated environment
• 5+ years of project management or site leadership experience
• Strong knowledge of change control, manufacturing processes, and regulatory compliance (EU MDR preferred)
• Proven ability to lead cross-functional teams and execute within strict regulatory timelines

Key Competencies

• Strong project execution and organizational skills
• Ability to operate with autonomy in a fast-paced, regulated environment
• Excellent communication and stakeholder management skills
• Experience supporting audits, inspections, and regulatory submissions