Manufacturing Engineer II - Shockwave

This job is with Johnson & Johnson, an inclusive employer and a member of my Gwork – 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 Med Tech, 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

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:

Description - External     Johnson & Johnson is hiring for a   Manufacturing Engineer II - Shockwave Medical     to join our team located in   Santa Clara, CA  .
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 Med Tech, 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   
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 Manufacturing Engineer II is responsible for providing engineering support to Production. Also responsible for designing, developing, testing, and implementing processes, tooling, and fixtures for commercial product. In addition, the Manufacturing Engineer II will sustain activities on the production line such as raw material, process and equipment issues.
Essential Job Functions
Actively collaborate with Production to provide sustaining support in resolving product/process/equipment problems.
Actively identify and participate in process/product, tooling, equipment, fixtures and cost reduction improvement projects.
Coordinate and/or perform functional and destructive testing to support Engineering Reports. Document the results and provide a statistical analysis using Minitab or excel.
Participate as an extended team member for new product introduction, including scaling up, stabilizing and transfer to alternate sites.
Participate in development and maintenance of process FMEAs, Manufacturing Process Instructions (MPIs), and Device Master Record (DMR) documents.
Create, maintain and transfer paper Bill of Materials (BOM's) and Lot History Records (LHR's) into Item Structures, Work Definitions and electronic LHR's.
Support efforts to resolve Quality related events (NCR, CAPA, Audit Finding) and maintain other Quality System Requirements.
Create and release label files used for printing product labels.
Create and execute process validation protocols and reports.
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.
Qualifications - External
Bachelor's degree in engineering.
3-5 years of experience in a medical device environment.
Knowledge of and compliance with applicable Quality System requirements such as QSRs, FDA, ISO, MDD, MDR and other applicable regulations.
Understanding of Lean and Six Sigma concepts.

Experience with Validation of…