Staff Manufacturing Engineer - Shockwave Medical

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 Staff Manufacturing 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 Staff Manufacturing Engineer is responsible for designing, developing, testing, validating, and implementing processes, tooling, and fixtures for on-market products. The Staff Manufacturing Engineer will work closely with integration teams and serve as a core member of the team through successful implementation into the company’s manufacturing operations.

 

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. 

• Lead and/or actively participate in efforts to integrate new systems into the production environment. Prepare user requirements, functional requirements, participate in validations, transfer of data from legacy systems and end user training.

• Identify process requirements, advise and support operations management, and implement equipment and fixturing needed for process improvement 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. 

• 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). 

• 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 al