Staff Manufacturing Engineer, Shockwave Medical

Company: Disability Solutions
Location: Santa Clara
Posted on: February 8, 2025

Job Description:

Johnson & Johnson is hiring for a Staff Manufacturing Engineer, Shockwave Medical to join our team located in Santa Clara, CA.\rAt 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/.\rFor more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges. We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.\rAt Johnson & Johnson, we all belong.\rShockwave Medical, Inc., recently acquired by Johnson & Johnson, is a pioneer in the development and commercialization of Intravascular Lithotripsy (IVL) to treat complex calcified cardiovascular disease. Shockwave Medical 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.\rPosition OverviewThe 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.\rEssential Job Functions

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• 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 existing products), providing solutions that improve efficiency and scalability for years to come.
• Identify opportunities and implement cost reduction plans for existing products.
• Support the transfer of product lines and the qualification-validation efforts.
• Other duties as assigned. These job requirements are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel.\r\r

Keywords: Disability Solutions, Santa Clara , Staff Manufacturing Engineer, Shockwave Medical, Healthcare , Santa Clara, California