Senior Strategic R&D Project Leader - Medical Devices

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

Proficiency in Project management tools (e.g. MS project, smart sheet, etc.)

Strong presentation and communication skills with technical and non-technical leadership teams

Experience in highly regulated environments – medical device, combo device, life sciences, aerospace

Knowledge of ISO 13485, EU MDR, and Good Manufacturing Processes and QMS documentation needs

Delivering and driving best practices and culture within teams across multiple sites for world class project execution

Ability to travel

up

to 35%.
Preferred Qualifications:
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, etc.
Experience across multiple types of medical devices – consumable/catheters, capital systems, and class III

Systems engineering requirements management

Why Laborie:
Our Mission every day is to operate as a world-class specialist medical company making and advancing technologies that preserve and restore human dignity. We do that today by helping people with pelvic and gastrointestinal conditions live normal lives, and by helping mothers and babies have safe deliveries.
Paid time off and paid volunteer time
Medical, Dental, Vision and Flexible Spending Account
Health Savings Account with Company Funded Contributions
401k Retirement Plan with Company Match
Parental Leave and Adoption Services
Health and Wellness Programs and Events
Awarded 2024 Cigna Healthy Workforce Designation Gold Level
Laborie

provides

equal employment opportunities and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Laborie is committed to providing access and reasonable accommodation in our services, activities, education, and employment for individuals with disabilities.

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