Product Development Project Manager

A medical device client in New Hope/Maplewood, Minnesota is looking for a Senior Project Manager to lead complex, customer-facing development projects. This engineering professional will serve as the primary point of contact for customers, manage cross-functional teams, and ensure projects are delivered on time, within budget, and in full compliance with Quality Management System (QMS), FDA QSR (21 CFR 820), and ISO 13485 standards.

We are looking for someone who can start their role in New Hope but transition to Maplewood once operations transfer.

What You’ll Do

• Manage project scope, schedule, and budget based on customer quotes/proposals.
• Drive multiple, concurrent, technically challenging development projects to successful completion.
• Identify and mitigate project and business risks through proactive planning.
• Serve as the primary customer liaison throughout the project lifecycle.
• Maintain strong customer relationships through regular updates, health reports, and meetings.
• Lead and contribute to technical design reviews and phase-gate reviews.
• Provide hands-on technical support to resolve engineering challenges.
• Ensure comprehensive and compliant documentation, including Design History Files.
• Ensure strict adherence to internal and customer QMS requirements.
• Ensure all project deliverables comply with FDA QSR (21 CFR 820) and ISO 13485.
• Delegate responsibilities and drive accountability across cross-functional teams.
• Mentor R&D engineers on project management and development best practices.
• Collaborate with Business Development on defining project scope and preparing accurate proposals.
• Support resource planning and revenue forecasting in partnership with management.

Qualifications Of Role

• Bachelor’s degree in a relevant engineering or technical discipline
• 8 or more years of experience in medical device product development.
• 3 or more years of experience in project leadership or project management.
• Strong understanding of design control and regulatory requirements (FDA, ISO 13485).
• Proven track record managing full product life cycle—from concept through manufacturing transfer.
• Proficiency with Microsoft Project or similar project management tools.
• PMP certification or formal project management training would be ideal
• Experience with catheter, minimally invasive, or similar complex medical devices is ideal

Salary of $100,000 - $150,000 Annually + 8% Bonus