This is an R&D Project Manager role in Roseville, MN. In this role, you will lead cross-functional development projects from concept through commercialization. Reporting directly to the Chief Technology Officer, this role is critical to ensuring our next-generation products meet clinical needs, regulatory requirements, and commercial goals. The ideal candidate is an engineer by training with proven experience driving complex projects in the medical device industry. You thrive at the intersection of engineering, operations, and commercialization—balancing technical detail with big-picture execution.
As an R&D Project Manager, you will:
- Lead cross-functional project teams through all phases of the product lifecycle (concept, design, verification/validation, transfer, launch).
- Develop and manage project plans, timelines, budgets, and deliverables.
- Collaborate closely with R&D, operations, quality, and regulatory teams to ensure alignment.
- Drive risk management activities, design reviews, and documentation to meet ISO 13485 and FDA requirements.
- Anticipate roadblocks and proactively resolve issues to keep projects on track.
- Communicate progress and challenges to leadership, providing clear visibility into project health.
- Contribute hands-on engineering expertise where needed, while ensuring the overall project stays on course.
What You’ll Need
- Bachelor’s degree in Engineering (Mechanical, Biomedical, or related). Master’s degree preferred.
- 5–10+ years of engineering experience in the medical device industry, with at least 3 years in project management or technical leadership roles.
- Demonstrated success managing complex R&D or product development projects.
- Deep understanding of design controls, quality systems, and regulatory pathways (FDA, CE).
- Strong communication and leadership skills to motivate cross-functional teams.
- Comfortable working in a fast-paced, high-growth company where you wear multiple hats.
Perks of the Job
Compensation:
- $160K base + 15% bonus (~$184K total comp)
Other Benefits:
- Medical:
- Health Partners Medical ($3,200 deductible plan, 100% coverage thereafter)
- Dental and Vision (EyeMed) with an HSA (no corporate contribution to HSA). Company covers premiums at 85% for employee and 70% for dependents.
- Vision plan is optional and paid 100% by the employee.
- 11 Paid holidays per year.
- 401K and Roth IRA (no company match).
Job Type: Full-time
Pay: $160,000.00 - $185,000.00 per year
Experience:
- Medical Device Engineering: 3 years (Required)
- Project Management: 2 years (Required)
Location:
- Arden Hills, MN 55113 (Required)
Work Location: In person
