Manufacturing 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 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 Manufacturing Engineer II – 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 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.

Requirements

• Bachelor’s degree in Engineering.

• 3-5 years of experience in a medical device environment.  

• Understanding of Lean and Six Sigma concepts.

• Basic understanding of Statistics (Cpk, Hypothesis Testing, DOE’s, Gage R&R) a plus.

• Able to create and maintain Drawings in SolidWorks.

• Experience with ERP and MES (Oracle preferred)

• 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.

• Employee may be required to lift objects up to 25lbs or more. Employee will be required to work in an air-conditioned Class 8 Cleanroom.  

Additional Information

Subject to the terms of their respective plans, employees are eligible to participate in the Comp