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Salary: USD 91,000 - 147,200 / annual
Johnson & Johnson is hiring a Senior Design Quality Engineer for Shockwave Medical in Santa Clara, CA. Shockwave Medical, a J&J company, develops Intravascular Lithotripsy (IVL) technology to treat complex calcified cardiovascular disease through proprietary local delivery of sonic pressure waves.
In this role, you will serve as the Quality Design Engineering Assurance lead for hardware and embedded software systems, partnering across internal departments to deliver safe, effective medical device designs for manufacturing. You will ensure compliance with Shockwave Medical policies, customer requirements, corporate standards, and regulatory guidelines including ISO 13485, ISO 14971, 21 CFR Part 820, MDD 93/42/EEC, EU MDR, MDSAP, IEC 62304, IEC 62366, and IEC 60601.
Key responsibilities include:
- Ensuring new design projects and design change activities comply with medical device regulations, standards, and internal procedures
- Participating in design reviews to document and verify designs meet customer requirements
- Developing, reviewing, and performing embedded software and hardware system design verification and validation test plans, protocols, and reports
- Serving as subject matter expert on relevant standards and statistical techniques for design and development projects
- Managing risk management documentation including Risk Management Plans, FMEA, and Risk Management Reports
- Developing device Quality and System V&V Plans aligned with Quality Management System requirements
- Auditing Design History Files (DHFs) for Design Control compliance
- Qualifying molds, fixtures, tooling, and equipment
- Supporting process validations and driving process improvements
- Supporting regulatory submissions and product approval processes
- Identifying testing and analysis required for product specification conformance
- Supporting hardware scalability and continuous improvement initiatives
- Initiating, reviewing, and approving Document Change Orders
- Collaborating with manufacturing and contract manufacturers to maintain product quality and resolve non-conformances
- Performing root cause analysis of product non-conformances
- Evaluating and documenting investigations for returned devices and commercial complaints
- Reviewing, investigating, and driving completion of Non-Conforming Reports (NCRs) and Corrective and Preventive Actions (CAPAs)
- Analyzing quality metrics to identify trends
- Participating in internal, supplier, and third-party audits (FDA, FDB, Notified Body)
- Supporting Quality Management System implementation and continuous improvement
- Recommending QC sampling plans based on confidence and reliability limits
- Participating in Supplier Quality activities
Requirements:
- Bachelor's degree in software or electrical engineering with 5+ years of hands-on experience with embedded software, hardware design and development, and system-of-system design verification and validation testing in the medical device industry; OR Master's degree with 3+ years of equivalent hands-on 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, and MDSAP
- Experience with analog and digital circuit design, schematic layouts, PCB layout/design, prototype development, automation tests, server component validation, stress and reliability tests
- Experience with design and development of embedded systems, source version control, issue tracking, power and control electronics for medical devices
- Class III medical device experience and electromechanical device product knowledge
- Ability to perform multiple tasks concurrently with accuracy
- Ability to understand regulatory implications of design changes
- Ability to lead cross-functional teams in problem solving and risk analysis
- Proficiency in MS Word, Excel, and PowerPoint
- High attention to detail and accuracy
- Ability to communicate effectively at all organizational levels
- Ability to lift objects up to 25 lbs
Preferred qualifications:
- Programming experience with embedded systems
- Experience and involvement with complaint investigations, MDRs, and Vigilance Reporting
- Experience with statistical software such as Minitab and application of valid statistical techniques for data analysis
- GAMP (Good Automated Manufacturing Practice) knowledge
- Lean Supply Chain Management experience
