Manufacturing Engineer - Shockwave

Position: Staff Manufacturing Engineer - Shockwave
This job is with Johnson & Johnson, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

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 Med Tech, 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

Job Function:
Supply Chain Engineering

Job Sub     Function:
Manufacturing Engineering

Job Category:
Scientific/Technology

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

Job Description:

Description - External     Johnson & Johnson is hiring for a   Staff Manufacturing Engineer, 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 Med Tech, 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   
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 Staff Manufacturing Engineer is responsible for designing, developing, testing, documenting, and implementing processes, tooling, and fixtures for throughout the product lifecycle, from design to production. The Staff Manufacturing Engineer will work closely with production, quality, and R&D teams to support the company's manufacturing operations and product launch timelines.
Essential Job Functions
Work collaboratively with R&D, QA and Production departments to design, develop, test, document and implement processes, tooling, and fixtures.
Collect data and analyze process performance and capabilities for company products, including new products and products already in production.
Perform tolerance analysis for components, manufacturing materials, packaging, and supplies used for in-house processing.
Lead effort to develop and maintains process Failure Modes and Effects Analyses (pFMEAs) for company processes.
Prepare user requirements, technical specifications, and design specifications.
Identify process requirements, advise and support operations management, and implement equipment and fixturing needed for process development and manufacturing efforts.
Develop and maintain documentation for design control, product configurations, manufacturing procedures, lot history records, (e.g., bills-of-materials, MPI's, LHR's), and other Quality System requirements.
Evaluate existing engineering processes and implements process improvements.
Lead and/or actively participate in product/process engineering problem solving using DMAIC methodology.
Lead and/or actively participates in process/product improvement projects (in cooperation with production, R&D engineers and technicians).
Assist Procurement and R&D departments with supplier selection and technical development.
Recommend new technologies to improve system performance and reliability. Performs productivity and costing analyses (e.g., calculate direct labor, time studies& materials costs for new and…