Manager, R&D - Shockwave Medical - New Brighton, Minnesota
About the role
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/.
The position is located in New Brighton, Minnesota, United States.
Job Function: R&D Product Development; Job Sub Function: Biomedical Engineering; Job Category: People Leader.
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.
Responsibilities
- 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