Project Manager, Medical Device
MEDELA LLC
McHenry, IL
Hybrid Role: 3 days a week on-site.
Candidate needs to be within commuting distance to McHenry, IL.
Starting salary: $105K
Project Manager – Medical Device Product Development
Lead innovative product development projects from concept through commercialization in a global medical device environment.
- We are seeking an experienced and highly motivated Project Manager to lead cross-functional product development projects from initiation through successful product launch.
- This position offers an exciting opportunity to work with global engineering and R&D teams, drive innovation, and contribute to the development of high-quality medical devices that make a meaningful difference in healthcare.
The ideal candidate brings a strong background in medical device product development, excellent project management skills, and the ability to lead diverse teams across multiple disciplines and international locations.
Success in this role requires a proactive, results-oriented professional who can manage complex projects, anticipate challenges, and keep teams aligned on priorities, timelines, budgets, and quality expectations.
Responsibilities-Project Manager, Medical Device
- Lead Product Development Projects: Manage complex medical device development projects from initial concept and business case through design, development, validation, and commercial launch.
- Drive Cross-Functional Collaboration: Coordinate global project teams across R&D, Engineering, Marketing, Operations, Supply Chain, Quality, and Regulatory Affairs to ensure alignment and successful execution.
- Manage Global Partnerships: Collaborate with internal teams and external development partners across the United States, Switzerland, and China, leveraging the expertise of each organization to achieve project objectives.
- Own Project Planning and Execution: Develop and manage project plans, milestones, budgets, resource requirements, deliverables, and launch schedules while maintaining accountability for project performance.
- Identify and Mitigate Risks: Proactively assess technical challenges, project dependencies, resource constraints, and potential delays. Develop solutions and escalate critical issues to maintain project momentum.
- Ensure Regulatory Compliance: Oversee project execution in accordance with medical device regulatory requirements, design controls, quality standards, and established product development processes.
- Support Technical Development: Partner with engineering and technical teams to incorporate risk management, FMEA, requirements engineering, and appropriate development methodologies throughout the product lifecycle.
- Lead Project Reviews and Communication: Facilitate project meetings, communicate progress to key stakeholders, prepare recommendations, and present project status and decisions to leadership.
- Maintain Documentation and Launch Readiness: Ensure complete and accurate project documentation, including technical files, and coordinate activities required for successful product launches.
- Champion Continuous Improvement: Introduce and reinforce project management processes, tools, and best practices that improve team effectiveness, project execution, and overall product development performance.
What We're Looking For
Qualifications-Project Manager, Medical Device
- Bachelor's degree in Mechanical Engineering, Electrical Engineering, Systems Engineering, Information Technology, Natural Sciences, or a related technical discipline. Preferred: Master’s degree in Engineering, Science, Business Administration, or a related field.
- Project management certification or formal training, such as PMP or equivalent.
- Direct experience managing medical device development projects from concept through commercial launch.
- Minimum of 5 years of experience in product development, with demonstrated involvement in managing or coordinating complex development projects.
- Strong project management experience, including project planning, scheduling, budgeting, resource allocation, risk management, and stakeholder communication.
- Experience working in a highly regulated industry, preferably medical devices.
- Knowledge of product development lifecycles, design controls, R&D processes, and cross-functional engineering disciplines.
- Familiarity with FDA design controls, ISO 13485, risk management, FMEA, and medical device technical documentation.
- Understanding of manufacturing, industrialization, and supply chain considerations associated with bringing new products to market.
- Experience collaborating with cross-functional teams in a global or matrixed organization.
- Experience with structured product development processes, stage-gate methodologies, and project portfolio management tools
- Strong communication, organizational, analytical, and problem-solving skills.
- Demonstrated ability to influence, motivate, and lead project teams without direct reporting authority.
- Travel: Up to 10% including occasional international travel.
What We Offer our Project Manager, Medical Device
Comprehensive benefits plan
401K with match
Money Purchase Plan
16-week Paid Parental Leave
Generous PTO package, plus 14 paid holidays
A great place to work!
This is not a job description. More details will be provided regarding the functions of this position.
At Medela, you will be joining a global community of colleagues, united by the purpose that drives our business: helping people. Medela exists to advance human health and well-being through knowledge-based and innovative human milk and medical vacuum solutions.
If you are interested in this opportunity, we are looking forward to receiving your application.
For this position we only consider direct applications - thank you for your understanding.
As an EEO/Affirmative Action Employer, all qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, ancestry, citizenship, sex, protected veteran status, age, physical or mental disability, medical condition, HIV/AIDs status, marital status, domestic partner status, sexual orientation, gender identity (transgender status), weight, height or any other characteristic protected by federal, state, or local law or ordinance.
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