Manager, R&D (Process Development) - Shockwave

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

Job Function:
R&D Product Development

Job Sub Function:
Biomedical Engineering

Job Category:
People Leader

All Job Posting Locations:
Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Manager, R&D (Process Development) to join our team located in Santa Clara, CA.

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 Process Development (PD) Manager of R&D provides leadership and technical support while effectively managing and developing direct reports.

Responsible for late-stage 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 late-stage cross-functional project activities from development through commercial release of product and beyond.


* Lead R&D activities for expansion of product into new global geographies.


* 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, including transfer to and scale up within manufacturing.


* Provide regular updates of key milestones ...