Sr. Design Quality Engineer- Shockwave Medical

Sr Design Quality Engineer – Shockwave Medical Position location: Santa Clara, California. This role supports the design, development, and validation of Shockwave Medical’s intravascular lithotripsy (IVL) devices and hardware systems to meet regulatory and quality requirements. Position Overview The Sr. Design Quality Engineer collaborates with Design, Manufacturing, and Regulatory teams to ensure all product designs comply with ISO 13485, IEC 62304, IEC 62366, IEC 60601, 21 CFR Part 820, and other applicable standards. The role focuses on embedded software and hardware system verification and validation, risk management, design control, and continuous process improvement. Essential Job Functions Ensure new design projects and design change activities comply with medical device regulations, standards, and internal procedures. Participate in design reviews to document and verify that the design meets intended customer requirements. Develop, review, and perform embedded software and hardware system design verification and validation test plans, protocols, and reports. Serve as subject‑matter expert on application of relevant standards and usage of statistical techniques for design and development projects. Responsible for risk‑management files including Risk Management Plan, Risk Analysis, FMEA, and Risk Management Reports. Develop device quality and system V&V plans to describe and manage elements of the Quality Management System. Provide software level of concern and classification for software modules. Audit Design History Files to ensure compliance with design‑control procedures. Assist in qualifying molds, fixtures, tooling, and equipment. Support process validations, identify and implement improvements, and support regulatory submissions. Identify testing and analysis required to ensure conformance to product specifications. Support hardware scalability and continuous improvement projects. Initiate, review, and approve Document Change Orders. Provide support for Manufacturing, Operations, contract manufacturers, and root‑cause analysis of non‑conformances. Evaluate investigations of returned devices from clinical studies and commercial complaints. Review, investigate, disposition, and close Non‑Conforming Reports (NCR) and Corrective and Preventive Actions (CAPA). Analyze quality metric data to identify significant trends. Drive Standard Gap Assessment activities. Participate in internal, supplier and third‑party audits (FDA, FDB, Notified Body, etc.). Implement and continuously improve the Quality Management System and provide technical support to the Quality inspection group. Recommend QC sampling plans based on desired confidence and reliability limits. Participate in Supplier Quality activities including material non‑conformances and supplier audits. Apply Johnson & Johnson Credo and Leadership Imperatives in daily interactions. Requirements Bachelor’s degree in software or electrical engineering (or similar) with 5+ years of hands‑on experience in embedded software, hardware design, and development. Experience with system‑of‑system design verification and validation testing in the medical device industry (or MS with 3+ years of relevant experience). Working knowledge of applicable medical device regulations and standards: ISO 13485, ISO 14971, IEC 62304, IEC 62366, IEC 60601, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP. Experience with analog and digital circuit design, schematic layout, PCB layout, prototype development, automation tests, server‐level validation, stress and reliability testing. Experience designing and developing embedded systems, source version control, issue tracking, power and control electronics for medical devices, and programming. Ability to perform multiple tasks concurrently with accuracy. Understanding of regulatory implications of design changes. Experience with complaint investigations, MDRs, and vigilance reporting (preferred). Leadership of cross‑functional teams in problem‑solving and risk analysis activities. Experience with statistical software (e.g., Minitab) for data analysis. Ability to work in a fast‑paced environment managing multiple priorities. Strong written and verbal communication skills at all organizational levels. Proficiency in MS Word, Excel, and PowerPoint. High attention to detail and accuracy. Capability to lift objects up to 25 lbs. EEO Statement Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, or any other characteristic protected by federal, state, or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. #J-18808-Ljbffr 6947-SHOCKWAVE MEDICAL INC. Legal Entity