Senior R&D Project Manager
The Senior R&D Project Manager leads cross-functional teams through the full lifecycle of medical device product development, from concept to commercialization. The role ensures compliance with regulatory standards and quality systems while managing project scope, timelines, and budgets.
- Compensation
- Not disclosed
- Location
- Maple Grove, United States; Salt Lake City, United States
- Work setup
- Not specified
- Seniority
- Senior
- Employment
- Contract
- Experience
- 3+ years
- Category
- Project management
- Posted
Skills
Must have
- B.S. in engineering or STEM
- 3-5 years in R&D and product/process development
- 5-7 years of project/program management experience
- Experience in highly regulated environments (medical device, combo device, life sciences, aerospace)
- Knowledge of ISO 13485, EU MDR, and Good Manufacturing Processes
- Proficiency in project management tools (e.g. MS project, smart sheet)
Nice to have
- Experience with FDA submissions (IDE, 510k, PMA)
- PMP Certification
- Experience in catheters and systems/capital based medical devices
- Structure problem solving methodology certifications (DMAIC, green belt, black belt)
- Systems engineering requirements management
Full description
We believe that great healthcare is an essential safeguard of human dignity.
At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you.
We support and empower our employees to grow their careers in an environment that encourages a sense of belonging and a connection to doing good. We’re not afraid to roll up our sleeves to make our goals a reality and work together to solve for our customers. We reward and recognize our employees based on our values of Aspire to Greatness, Respect All, Own It, Working Together, Persist with Passion.
Who We’re Looking For:
As a key member of the R&D team, the Senior R&D Project Manager will lead the planning and execution of new product development and technology from concept through commercialization, design transfer internally and externally, as well as product integration and key initiatives in R&D. This role drives cross-functional alignment, manages technical and regulatory complexity, and ensures disciplined cross-functional execution.
About the Role:
- Lead and deliver cross-functional projects from concept through commercialization and post-launch support, including NPD, QMS integrations, product improvements, business integrations, and strategic initiatives.
- Define project goals, scope, deliverables, timelines, success criteria, and resource requirements, ensuring alignment with business and R&D leadership priorities.
- Drive execution through all project phases, ensuring compliance with stage-gate processes, design controls, design transfer requirements, quality systems (QMS), regulatory standards, and Design for X principles.
- Develop integrated project plans and proactively manage risks, issues, dependencies, budgets, and decision-making to achieve project objectives.
- Establish and maintain effective cross-functional communication, collaboration, accountability, and stakeholder alignment to ensure successful milestone delivery.
- Identify opportunities for process improvement and implement best practices in project execution, risk management, and problem-solving to enhance project outcomes and organizational effectiveness.
Minimum Qualifications:
- B.S. in engineering or STEM (chemistry, physics, etc.), 3-5 years in R&D and product/process development in addition to 5-7 years of project/program management experience.
- Proven track record of delivering complex projects with cross-functional multidisciplinary teams within scope, budget, and timeline.
- Design transfer and planning of contract design and manufacturing streams.
- Strong planning and organizational skills with aptitude to lead without direct authority.