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Johnson & Johnson is hiring an NPI (New Product Introduction) Engineer II for Shockwave Medical, a division pioneering Intravascular Lithotripsy (IVL) technology to treat complex calcified cardiovascular disease. Based in Santa Clara, CA, this role focuses on the development and commercialization of innovative medical devices for peripheral, coronary, and heart valve disease treatment.
The NPI Engineer II will drive process development and oversee the transition of products from development into full production. Key responsibilities include collaborating with Production teams to resolve product, process, and equipment issues; identifying and leading process optimization and cost reduction projects; coordinating functional and destructive testing with statistical analysis; and participating in new product introduction activities including scaling, stabilization, and site transfer.
You will develop and maintain critical documentation including process FMEAs, Manufacturing Process Instructions (MPIs), and Device Master Records (DMRs). Additional duties encompass quality system support (NCR, CAPA, audit findings), Bill of Materials management, label file creation, and process validation protocol execution. This is a fully onsite position in a Class 8 Cleanroom environment.
Required qualifications: Bachelor's degree in Mechanical or Biomedical Engineering with minimum 3 years of medical device experience. Strong knowledge of Quality System requirements (QSRs, FDA, ISO, MDD, MDR regulations), Lean and Six Sigma concepts, and medical device validation (IQ-OQ-PQ). Technical skills include SolidWorks CAD, statistical analysis (Cpk, hypothesis testing, DOE, Gage R&R), and ERP/MES systems (Oracle preferred). Experience with disposable peripheral and coronary device design, catheter-based cardiovascular devices, and material selection is highly valued. Must demonstrate effective communication, ability to manage multiple priorities in a fast-paced environment, and flexibility to changing requirements.
