NPI Engineer II - 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 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  

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:*
* R&D Product Development

** Job Sub*
* ** Function:*
* Biomedical Engineering

** Job Category:*
* Scientific/Technology

** All Job Posting Locations:*
* Santa Clara, California, United States of America

*
* Job Description:

*
* Johnson & Johnson is hiring for a  
** NPI Engineer II**    **- Shockwave Medica
** l 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 NPI Engineer II will use technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. The NPI Engineer II will focus on process development for the engineering team, providing oversight to pilot manufacturing/testing, and see products transition from development into full production. This position will participate on multiple cross-functional development teams that focus on process optimization, sustaining, and design support.

The NPI Engineer II will develop, validate, and implement various processes by working closely with research/development, operations, regulatory, and quality teams. In addition, the NPI 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…