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 MedTech, 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. Learn more at jnj.com

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.

Job Function:

R&D Product Development

Job Sub Function:

Biomedical Engineering

Job Category:

People Leader

All Job Posting Locations:

New Brighton, Minnesota, United States of America

Job Description:

Johnson & Johnson is hiring for a Manager, R&D– Shockwave Medical to join our team located in New Brighton, MN.

 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 MedTech, 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. Learn more at https://www.jnj.com/.

 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.

Position Overview

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.

Essential Job Functions

• 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.

• R