Staff NPI Engineer - Shockwave Medical

Johnson & Johnson

Johnson & Johnson seeks a Staff NPI Engineer for its Shockwave Medical division in Santa Clara to develop manufacturing processes and tooling for intravascular lithotripsy devices treating cardiovascular disease. The role bridges product development and production, requiring expertise in process design, validation, and cross-functional collaboration.

Responsibilities

Design, develop, validate, and implement catheter manufacturing processes aligned with design intent
Collaborate across R&D, Operations, Quality, and Regulatory teams on process and tooling development
Develop technical documentation, drawings, and specifications for manufacturing equipment and fixtures
Conduct verification, validation, and in-vitro/in-vivo testing; analyze data and recommend design improvements
Lead process improvement initiatives using DMAIC methodology and develop pFMEA analyses

Requirements

Advanced degree in biomedical, mechanical, or chemical engineering
5+ years experience in medical device manufacturing process development
Proficiency with design for manufacturability and process optimization principles
Experience developing catheter or interventional device manufacturing processes
Knowledge of design control, quality systems, and regulatory compliance (ISO 13485, FDA)
Demonstrated expertise in tolerance analysis and failure modes analysis (FMEA)

Apply

Vacancy posted 2 days ago

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