Staff NPI Engineer - Shockwave Medical

Biomedical Engineering

Scientific/Technology

Santa Clara, California, United States of America

Johnson & Johnson is hiring for a Staff NPI Engineer – 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 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 https://www.jnj.com/.

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 Staff NPI Engineer will utilize technical skills in the development of innovative products to treat peripheral, coronary, and heart valve diseases. The Staff NPI Engineer will serve as a subject matter expert for the process development team, provide oversight to pilot manufacturing/testing, and guide products as they transition from development into full production. This position will participate in multiple cross-functional development teams, focusing on design for manufacturability, process optimization, and sustaining activities.

The Staff NPI Engineer will develop, validate, and implement various processes by working closely with R\&D, Operations, Regulatory, and Quality teams to support the company’s manufacturing operations and product launch timelines. This role is responsible for designing, developing, testing, documenting, and implementing processes, tooling, and fixtures throughout the product lifecycle—from design through production.

• •Collaborate with R&D, QA, and Production departments to design, develop, test, document, and implement processes, tooling, and fixtures.
• •Develop, validate, and maintain test methods.
• •Develop new catheter manufacturing processes based on design intent and DFM principles.
• •Develop and maintain technical documentation such as drawings for equipment, fixtures, components, and assemblies used in manufacturing processes.
• •Performs testing, analyzes results and provides recommendations for design selection.
• •Analyze, evaluate, source, and coordinate procurement of new materials to support prototyping pilot operations, and design verification and validation activities.
• •Develop protocols/reports and perform product in-vitro, in-vivo as well as verification and validation testing.
• •Participates in technical design reviews to ensure all design inputs and user needs are met.
• •Collect data and analyze process performance and capabilities for both new and existing products.
• •Perform tolerance analysis for components, manufacturing materials, packaging, and supplies used for in-house processing.
• •Lead efforts to develop and maintain Process Failure Modes and Effects Analyses (pFMEAs).
• •Prepare user requirements, technical specifications, and design documentation.
• •Identify process requirements, support operations management, and implement necessary equipment and fixtures needed for process development and manufacturing efforts.
• •Support product development teams in executing projects from concept to commercialization.
• •Contribute to base business and continuous improvement initiatives.
• •Support pilot manufacturing and serve as a subject matter expert on design-related inquiries, including regulatory submissions.
• •Ensure proper documentation and compliance with the company’s quality policy, system, and objectives.
• •Maintain documentation for design control, product configurations, manufacturing procedures, lot history records, (e.g., bills-of-materials, MPI’s, LHR’s), and other Quality System requirements.
• •Evaluate and improve existing engineering processes.
• •Lead or participate in problem-solving initiatives using the DMAIC methodology.
• •Lead or support process/product improvement projects in collaboration with R&D engineers and technicians.
• •Assist Procurement and R&D in supplier selection and technical development
• •Recommend and implement new technologies to enhance system performance and reliability.
• •Conduct productivity and costing analyses (e.g., time studies, direct labor/materials costs assessments), proposing scalable solutions.
• •Identify and implement cost reduction strategies for existing products.
• •Support produc