Manager, R&D - Shockwave Medical

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and Med Tech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

R&D Product Development

Biomedical Engineering

People Leader

New Brighton, Minnesota, United States of America

Johnson & Johnson is hiring for a Manager, R&D– Shockwave Medical to join our team located in New Brighton, MN. Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Ready to join a team that’s pioneering the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease.

Our Shockwave Medical portfolio aims to establish a new standard of care for medical device treatment of atherosclerotic cardiovascular disease through its differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque.

The Manager of R&D provides leadership, technical support, and effectively manages and develops direct reports. Responsible for product and process development, resources, and project management activities associated with executing the company's goals and objectives.

• Manage, lead, and mentor engineer(s) and/or technician(s).
• Lead all cross‑functional project activities from concept through clinical trial and commercial release of product.
• Mentor and support a variety of development and engineering activities, which mainly focus on catheter design and development.
• Design and develop product(s) in full compliance with the company's Design Control requirements and consistent with FDA, ISO and MDD requirements.
• Coordinate technical personnel and their activities involved in developing new and improved products and manufacturing processes.
• Ensure that development activities are properly documented through lab notebook, history file, and other records.
• Coordinate cross‑functional alignment and support for program success.
• Manage outside vendors and contractors providing products or services.
• Create, maintain, and communicate project timelines for internal and outside development projects.
• Provide regular updates of key milestones and issues to the project team as well as management.
• Identify issues and recommend solutions for products in development.
• Contribute ideas to new products, as defined by product specification requirements.
• Approve test methods, acceptance criteria, and test equipment for all stages of product development.
• Coordinate and participate in events, which provide clinical feedback such as animal studies, physician interface meetings, and Human Clinical Studies.
• Ensures that products satisfy acceptable quality standards and customer needs with consensus from cross‑functional groups.
• Review and approve documents as specified in Document Control SOP.
• Compile the Design History File and conduct design reviews in compliance with Design control procedures.
• Ensure that products have capable manufacturing processes and that process verifications and validations are completed.
• Interact with cross‑functional groups to ensure that products are compatible with other products in the intended operating system, and have met all requirements per design control process.
• Other duties as assigned.

• B.S. in Engineering or equivalent work experience.
• Minimum of 10 years’ progressive experience in medical device…