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 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.

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Supply Chain Engineering

Quality Engineering

Scientific/Technology

Santa Clara, California, United States of America

The Sr. Design Quality Engineer (Embedded Software and Hardware System Verification & Validation) works closely with internal departments to efficiently deliver safe and effective medical device designs for manufacturing in line with Shockwave Medical Inc. (SWMI) policies and procedures. This position represents Quality Design Engineering Assurance for hardware and embedded software design, development, system verification and validation and supports sustaining engineering to improve hardware, software, and equipment.

Responsibilities include ensuring new designs and change activities comply with regulations, participating in design reviews, developing verification and validation test plans, managing risk documents, auditing Design History Files, qualifying equipment, supporting regulatory submissions, identifying nonconformances, driving CAPA, analyzing quality metrics, facilitating audits, and providing technical support across manufacturing and operations.

• 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 Plans, 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 are 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.
• Performs/supports process validations, identifies, drives, and implements process improvements.
• 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.) and 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…