Project Manager – Medical Device

Title: R&D Project Manager – Medical Device
Location: Plymouth, MN
Work Schedule: Onsite, 5 days/week
Assignment: 12 Months C2H

Job Summary
We are seeking an experienced R&D Project Manager to lead medical device product development projects from planning through commercialization. The Project Manager will drive cross-functional execution, manage project schedules and budgets, identify and mitigate risks, and ensure project deliverables are completed on time and within scope.
The ideal candidate will have strong medical device industry experience, project management expertise, advanced MS Project skills, and proven experience leading cross-functional product development teams.

Key Responsibilities
• Lead cross-functional teams to execute medical device product development projects and achieve project deliverables.
• Define project scope, objectives, milestones, deliverables, priorities, and timelines.
• Develop and maintain detailed project plans, schedules, budgets, and resource plans using MS Project.
• Monitor project progress, milestones, dependencies, and critical paths; adjust plans as needed.
• Identify, assess, track, and mitigate project risks, issues, and dependencies.
• Develop mitigation strategies and escalate critical risks and issues to leadership.
• Coordinate with R&D, Quality, Regulatory, Clinical, Operations, Supply Chain, Process Development, and other functional teams.
• Manage project resources, budgets, timelines, and priorities.
• Prepare and present weekly/monthly project status reports to leadership and stakeholders.
• Lead project meetings, steering meetings, and ad hoc working sessions.
• Maintain project documentation, action trackers, schedules, and governance materials.
• Balance development timelines, product scope, resources, cost, and quality requirements.
• Drive projects toward key development milestones and commercialization.
• Support cross-portfolio strategy, budget, and resource planning discussions.
• Identify opportunities for continuous improvement and apply lessons learned.

Required Qualifications
• Bachelor's degree in Biomedical Engineering, Mechanical Engineering, or related field.
• 7+ years of leadership experience in medical device, biomedical, or high-technology industries.
• 4+ years of project management experience.
• Proven experience leading cross-functional product development teams.
• Medical device development experience, preferably involving catheter or implantable devices.
• Advanced experience with MS Project.
• Strong experience with project planning, scheduling, budgeting, and resource management.
• Demonstrated risk, issue, and dependency management experience.
• Ability to manage multiple projects and priorities simultaneously.
• Strong organizational, leadership, problem-solving, and communication skills.
• Experience with project management tools such as MS Project, Smartsheet, Excel, and PowerPoint.
• Familiarity with Agile, Scrum, Waterfall, or hybrid project methodologies.

Preferred Qualifications
• PMP certification.
• Advanced degree in Engineering, Sciences, Business Administration, or related field.
• Strong medical device product development experience.
• Experience with design/development through commercialization.
• Experience with stakeholder management and negotiation.
• Experience presenting project status and risks to senior leadership or steering committees.

Key Skills
• R&D Project Management
• Medical Device Product Development
• Cross-Functional Leadership
• MS Project
• Project Planning & Scheduling
• Risk & Issue Management
• Budget & Resource Management
• Stakeholder Management
• Project Monitoring
• Leadership & Communication
• Time Management & Prioritization
• Problem Solving