Sr. Quality Engineer- 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

Supply Chain Engineering

Quality Engineering

Scientific/Technology

Santa Clara, California, United States of America

Johnson & Johnson is hiring for a Sr Quality Engineer for Shockwave Medical Inc. 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.

The Sr. Quality Engineer will support manufacturing and work cross-functionally to resolve technical problems. Participates in decisions on scope of work, risk management, design changes, process improvements, material disposition, and implementation of revised specifications. Provides and develops solutions to broad problems, accomplishes complex assignments, develops protocols for design, and/or process activities, (including those related to verification or validation activities), determines criteria and subsequently generates summary (or final) reports.

• Responsible for developing, applying, revising and maintaining quality standards for processing materials/products into partially or finished products.
• Designs and implements methods and/or procedures for inspecting, testing and evaluating the precision and accuracy of products, components, sub-assemblies and/or production equipment.
• Analyzes nonconformance reports and returned products and recommends corrective action.
• Prepares documentation for inspection/testing procedures, development studies, validation protocols and reports, quality plans, product defect investigations and inspection plans. Must be able to write a technical document with sufficient clarity, detail and correctness to be submitted for regulatory review with confidence. Must be able to review and provide value-added feedback to others writing such documents.
• Fully competent engineer in all conventional aspects of the subject matter, functional area, and assignments.
• Plans and conducts work requiring judgment in the independent evaluation, selection, and substantial adaptation and modification of standard techniques, procedures, and criteria. Provides guidance to manufacturing and development engineers regarding documentation, process controls, data feedback systems, and best quality practices.
• Independently performs most assignments with an understanding of the overall expectations. Receives technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects.
• Plans, schedules, conducts, and coordinates detailed phases of engineering work in part of a major project.
• Performs work which involves conventional engineering practice…