Job Description
This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – 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 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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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 Johnson & Johnson is hiring for a Sr. Supplier Engineer - Shockwave Medical 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 Sr. Supplier Engineer is responsible for providing engineering support to Production team and external contract manufacturers.. This position leads the development, validation, and implementation of test equipment and fixtures for both development & commercial products. This role will troubleshoot complex and contributes to the resolution of technical challenges across Electrical and mechanical systems, support product transfers, and collaborate cross-functionally to ensure scalable, reliable and efficient manufacturing processes. . Essential Job Functions Serve as the primary technical point of contact for contract manufacturer and external partners, supporting the transfer and scale up of manufacturing processes. Supports development transfer activities between NPD, and operations to contract manufacturer/external partner. Design, develop, and maintain process risk documentation (e.g., PFMEA) to proactively identify and mitigate potential manufacturing issues. Prepare and execute engineering change orders and coordinate implementation activities, including training for production staff. Provides expertise in project planning and timeline development & management and maintain project schedules and timelines. Design, develop, and maintain testing fixtures, equipment, and manufacturing tools to support production and product validation. Collaborates with cross-functional teams to provide design for manufacturability (DFM) feedback during development phases. Develops, tests, and implements tools, fixtures and equipment required for manufacturing processes. Develop manufacturing process documentation, including work instructions, inspection plans and lot history travelers. Perform cost-reduction analysis and lead initiatives to improve product quality, and process efficiency. Lead the design transfer of new products to production, including establishing assembly time and yield targets, training, and quality control. Investigate product failures in collaboration with contract manufacturers to determine root cause and implement corrective actions to improve product reliability and performance. Ensure compliance with U.S. Food and Drug Administration (FDA) regulations, ISO standards, and internal quality systems. Ability to understand schematics and PCBA layout. Execute and document test protocols and reports for validating test equipment and medical devices. Troubleshoot and repair complex systems to the component level using schematics, layouts, and diagnostic tools. Provide hands-on support using standard laboratory equipment (Ex. Scope, multimeter, etc.)<