Quality Engineering Manager - 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 https://www.jnj.com

Job Function:

Supply Chain Engineering

Job Sub Function:

Quality Engineering

Job Category:

Scientific/Technology

All Job Posting Locations:

Santa Clara, California, United States of America

Job Description:

Johnson & Johnson is hiring for a Quality Engineer Manager – Shockwave Medical to join our team located in Santa Clara, CA.

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 Quality Engineering Manager provides leadership for Design Quality Engineering programs at Shockwave Medical. Works on problems and projects of moderate to complex scope where analysis of situation or data requires a review of identifiable factors. Participates in decisions on scope of work, risk management, length of tasks and compliance pathways. Supports project teams to ensure that new and existing products are designed and developed in accordance with customer, corporate, and regulatory guidelines. This manager will play a key role in building and sustaining a culture of Quality throughout the organization..

Essential Job Functions
Directly responsible for ongoing management, execution and improvements to the following Design Quality Engineering activities:

• Responsible for overseeing all aspects of Catheter Design Quality Assurance Engineering

• Responsible for oversight and management of Quality Engineers and Technicians supporting product design and development activities

  • Leads, supports, and mentors direct reports to develop a highly effective team

  • Sets goals for Design Quality personnel based on Corporate objectives

  • Provides guidance and ensures Quality personnel follow regulations and industry standards

• Participates in New Product Design and Development activities and provides Quality Engineering input, management, and guidance

  • Ensures new Design projects and Design Change activities are performed in compliance with Design Control procedure and relevant regulatory/user requirements

  • Attends design reviews to ensure that the design meets the intended regulatory, internal, and external customer requirements

  • Reviews/ Approves Design Verification and Validation (DV&V) Test Protocols, Methods and Reports

  • Subject Matter Expert on application of relevant standards, test sample sizes and usage of statistical techniques for new Design and Development Projects

  • Oversees verification/ validation activities for Biocompatibility Testing, Packaging Validation, Accelerated and Real Time Shelf-Life/Aging Studies, Sterilization Validation, Test Method Validation, Other DV&V tests

  • Provides technical assistance/guidance and training to the QC function related to inspection methodologies, techniques, processes, and requirements for new products/parts/components

  • Oversees testing and anal