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 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 late-stage product development.

• Coordinate and participate in events, which provide clinical feedback such as animal studies, physician interface meetings, and human clinical studies.

• Ensure 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.

• 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.

Requirements

• B.S. in Engineering with a minimum of 10 years’ progressive experience in medical device development, including 3+ years’ experience in leading projects in late-stage product development.

• 2 years’ experience managing direct reports or other relevant experience.

• Knowledge of QSR and applicable Quality System Standards.

• Experience with disposable medical device de