Staff Manufacturing Engineer (NPI) - Shockwave

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:

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 Staff Manufacturing Engineer (NPI) - 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 Staff Manufacturing Engineer is responsible for designing, developing, testing, documenting, and implementing processes, tooling, and fixtures throughout the product lifecycle - from design through production. The role works closely with the R&D Process Engineer (the Subject Matter Expert) to obtain critical information for product process development.  The Staff Manufacturing Engineer also collaborates with  Production, Quality, and R&D teams to support manufacturing operations and product launch timelines.

Essential Job Functions

• Collaborative with R&D, QA and Production departments to design, develop, test, document, and implement manufacturing processes, tooling, and fixtures. 

• Design and develop manufacturing processes in compliance with the company’s Design Control and applicable regulatory requirements.

• Collect and analyze data on process performance and capabilities for both new and existing products. 

• Prototype and develop proof-of-concept designs and bench models to test concepts in simulated environments.

• Develop, validate, and maintain test methods.

• Perform tolerance analysis for components, materials, packaging, and supplies used in-house processing. 

• Lead the development and maintenance of process Failure Modes and Effects Analyses (pFMEAs). 

• Prepare user requirements, technical specifications, and design specifications.

• Identify process needs, support operations management, and implement required equipment and fixturing development and manufacturing. 

• Develop and maintain documentation in support of 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 or actively participate in product/process engineering problem-solving using DMAIC methodology. 

• Lead or support process and product improvement projects in collaboration with production, R&D engineers and technicians. 

• Assist Procurement and R&D departments with supplier selection and technical development. 

• Recommend and evaluate new technologies to improve system performance and reliability.

• Conduct productivity and cost analyses, including direct labor, time studies& materials cost estimates, offering solutions to improve efficiency and scalability.

• Create a stability matrix in Phase 4 to assess the sustainability of product transfer. Sustaining Engineering will maintain sustainability, with support from the Staff Manufacturing Engineer. 

• Identify cost-reduction opportunities and implement savings strategies for existing products.

• Support the product line transfers and qualification/validation efforts.

• Perform other duties as assigned. T