Manufacturing Engineer - Shockwave Medical

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Supply Chain Engineering

Manufacturing Engineering

Scientific/Technology

Santa Clara, California, United States of America

Johnson & Johnson is hiring for a Manufacturing Engineer I – 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.

The Manufacturing Engineer I is responsible for providing manufacturing engineering support to Product Development teams. The Manufacturing Engineer is also responsible for designing, developing, testing, and implementing processes, manufacturing work instructions, tooling, and fixtures for products in the Product Development process.

• Work collaboratively with R&D and Production departments to design, develop, test, and implement processes, tooling, and fixtures.
• Support Process Validation activities in accordance with the Design Control process.
• Perform process characterization of new manufacturing processes, evaluate Design of Experiments data, and make improvements to optimize processes used to manufacture new products.
• Write robust manufacturing process instructions to be used in a production environment.
• Collect data and analyze process performance and capabilities for new products.
• Perform tolerance analyses for components, manufacturing materials, packaging, and supplies used for in-house processing.
• Lead effort to develop and maintain process Failure Modes and Effects Analyses (pFMEAs) for company processes.
• Develop and maintain documentation for design control, product configurations (e.g., bills-of-materials), and other Quality System requirements.
• Lead and/or actively participate in product/process engineering problem resolution and improvement projects (in cooperation with R&D engineers and technicians).
• Assist Materials and R&D departments with supplier selection and component development.
• Perform productivity and costing analyses (e.g., calculate direct labor & materials costs for new products).
• Support product transfer to additional manufacturing sites, if applicable.
• 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.

• Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, or equivalent experience.
• Between 0-3 years of experience in a medical device environment.
• Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD and other applicable regulations.
• Ability to work in a fast-paced environment while managing multiple priorities.
• Operate as a team and/or independently while demonstrating flexibility to changing requirements.
• There may be continuous sitting for prolonged…