Sr. Design 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 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: Quality Engineering Job Category: Scientific/Technology All Job Posting Locations: Santa Clara, California, United States of America Job Description: Johnson & Johnson is hiring for a Sr Design Quality 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 Sr. Design Quality Engineer (Embedded Software and Hardware System Verification & Validation) works closely and partners with internal departments to efficiently deliver safe and effective medical device designs for manufacturing, which are in line with Shockwave Medical Inc. (SWMI) policies and procedures. This position will represent Quality Design Engineering Assurance for hardware and embedded software design, development, design system verification and validation and support sustaining engineering to drive improvements with respect to hardware, software, and equipment. This includes supporting project teams to ensure that new and existing products are designed and developed in accordance with customer, corporate, and regulatory guidelines as well as working closely with Design and Manufacturing Engineering to improve processes where possible. Provides Quality Assurance support to functions with a focus on process improvements and design control compliance in accordance with ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP, IEC 62304, IEC 62366, and IEC 60601. Essential Job Functions Ensures new Design projects and Design Change activities are performed in compliance with medical device regulations, standards, and internal procedures. Participates in Design reviews to document and ensure that the design meets the intended customer requirements. Develops/Reviews/Performs Embedded Software and Hardware System Design Verification and Validation Test Plan, Test Protocols, and Reports. Is a Subject Matter Expert on application of relevant standards, usage of statistical techniques for new Design and Development Projects. Responsible for Risk Management files documents such as Risk Management Plan, Risk Analysis, Failure Mode and Effects Analysis (FMEA), Risk Management Reports. Develops device Quality and System V&V Plans to ensure that the elements of the Quality Management System is appropriately described and managed. Provides Software level of concern and classification of Software modules. Audits DHFs to ensure compliance with the Design Control procedure. Assists in qualifying molds, fixtures, tooling, and equipment. Perform/support process validations, identify, drive, and implement process Supports ongoing Regulatory submission activities and product approval processes. Identifies testing and analysis required to ensure conformance to product specifications. Supports hardware scalability and continuous improvement projects Initiates, reviews, and approves Document Change Orders (DCO.) Provides support for Manufacturing and Operations. Works with contract manufacturers to maintain product quality and resolve any non-conformances that arise. Performs or assists in root cause analysis of product non-conformances found in manufacturing. Evaluates/investigates and documents investigation results for returned devices from clinical studies and commercial complaints. Reviews, investigates, dispositions, and drives to completion Non-conforming Reports (NCR) and Corrective and Preventive Actions (CAPA.) Analyzes and reviews data for key Quality metrics to identify any significant trends. Drives Standard Gap Assessment activities. Participates in internal, supplier and third-party audits (FDA, FDB, Notified Body, etc.) • Participates in the implementation and continuous improvement of the Quality Management System. Provides technical support to the Quality inspection group. Recommends QC sampling plans based on desired confidence and reliability limits. Participates in Supplier Quality activities including material non-conformances and Supplier audits. J&J Cre