Job Description
Job DescriptionA medical device client in New Hope, Minnesota is seeking a Research & Development (R&D) Project Manager to lead complex, customer-facing development projects. This individual 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.This role combines project management, technical leadership, and cross-functional coordination, requiring a strategic thinker with strong engineering acumen and customer-facing experience.Key Responsibilities
- Project Management
- 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.
- Customer Engagement
- Serve as the primary customer liaison throughout the project lifecycle.
- Maintain strong customer relationships through regular updates, health reports, and meetings.
- Technical Leadership
- 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.
- Compliance & Quality
- Ensure strict adherence to internal and customer QMS requirements.
- Ensure all project deliverables comply with FDA QSR (21 CFR 820) and ISO 13485.
- Team Leadership
- Delegate responsibilities and drive accountability across cross-functional teams.
- Mentor R&D engineers on project management and development best practices.
- Strategic Support
- Collaborate with Business Development on defining project scope and preparing accurate proposals.
- Support resource planning and revenue forecasting in partnership with management.
Qualifications
- Bachelor’s degree in a relevant engineering or technical discipline.
- Minimum 5 years of experience in medical device product development.
- At least 1 year 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.
Preferred:
- Bachelor’s degree in Plastics, Biomedical, or Mechanical Engineering.
- PMP certification or formal project management training.
- Experience with catheter, minimally invasive, or similar complex medical devices.
Salary of $85,000 - $125,000 Annually + 8% Bonus