Project Manager - MGC

Essential Functions

• Lead full lifecycle project management of new product development (NPD) for Class II FDA-regulated medical devices, from concept through design transfer and commercial launch.
• Develop and maintain integrated project plans, timelines, resource forecasts, risk registers, and budgets aligned to program objectives.
• Ensure compliance with global medical device regulations including FDA (21 CFR Part 820), ISO 13485, ISO 14971, IEC 60601, and other applicable international standards.
• Drive execution of product development through a stage-gate process, ensuring quality system deliverables.
• Collaborate with external partners and suppliers, supporting technical and operations leads to manage vendor deliverables and timelines.
• Facilitate formal design reviews, technical documentation review, and risk management activities.
• Prepare and deliver regular program status updates to senior leadership, including project health, milestones, and risk mitigation strategies.
• Track departmental and project performance through established KPIs, and prepare regular status reports for leadership and key stakeholders.
• Support regulatory submission activities (e.g., 510(k), technical file, global registrations) in collaboration with Regulatory Affairs.

Competencies/Success Factors

• Detail Orientation
• Project/Task Management
• Results Focus/Output Orientation
• Personal Energy/Enthusiasm
• Team Orientation
• Interpersonal Communication
• Leadership
• Problem Solving

Physical Demands

• Frequent standing, sitting, walking, bending, stooping, twisting
• Occasional lifting up to 50 lbs., occasional heavier lifting
• Occasional pushing, pulling and handling of materials

Additional Eligibility Qualifications

• None required for this position.