The Cardiovascular & Specialty Solutions (CSS) Group, part of the Medical Devices sector within Johnson & Johnson, is recruiting for a Principal Software Quality Engineer aligned to Advanced Sterilization Products, located in Irvine, CA. The CSS Group consists of six diverse businesses including Acclarent, Advanced Sterilization Products (ASP), Biosense Webster (BWI), Codman Neuro, Mentor, and Sterilmed. The CSS Group serves a diverse base of customers in Ear, Nose and Throat (ENT), Infection Prevention, Electrophysiology (EP), Neurovascular and Neurosurgery, Surgical and Non-Surgical Aesthetics, and Reprocessing.
This position is specific to:
Advanced Sterilization Products (ASP), division of Ethicon, Inc., a Johnson & Johnson company, truly makes a difference by Protecting Lives against Infection®. ASP has been innovating since 1987 to help healthcare facilities protect patients with best-in-class infection prevention solutions. Learn more about Advanced Sterilization Products at www.aspjj.com/us.
The Principal Software Quality Engineer applies advanced Quality Engineering/Scientific Method techniques and principles to daily tasks and activities. In addition, applies relevant regulations, standards, GxP requirements, and industry best practices to assignments. Plans and conducts projects and activities with moderate to high technical responsibility, complexity, and strategic input. Act’s as a subject matter expert in routine Quality Engineering and scientific matters. Develops and leads key strategic Quality Engineering/scientific initiatives throughout the organization. Receives occasional, summary instructions from senior technical Quality leaders, in addition to other senior level functional leaders.
Key Technical Responsibilities
• Demonstrates high level of proficiency in applying established tools and methods to identify and realize new product or process introductions.
• Partners with senior technical leaders (both internal and external to organization) to develop innovative approaches for realizing technical opportunities.
• Leads, contributes to assessments of product design.
• Leads, contributes to the utilization of, and/or develops innovative applications for various risk management and risk mitigation tools and practices (for example, mistake proofing, critical control points, failure mode and effects analysis).
• Leads, and/or contributes to, root cause investigations using various problem solving techniques and tools (Ex. K-T analysis), and assesses effectiveness of corrective actions.
• Leads, and/or contributes to, the development of new detection systems by developing optimal methods for conducting software system development, process, and product qualifications/validations.
• Collaborates with senior technical leaders to develop best practices for system/software development methods.
• Mentors others in various technical capabilities.
• Leads or participates in technical reviews as appropriate
• Executes strategic vision or plan by collaborating with other quality leaders to identify required needed software quality engineering skills and competencies.
• Other duties as assigned.
• Bachelor’s degree (or equivalent) in Engineering (software, computer, computer science or electrical) AND 12 or more years of relevant experience OR Graduate degree AND 8 or more years of relevant experience.
• ASQ CSQE desired
• ASQ CQE, CQM, CQA; Process Excellence yellow, green or black belt optional
• Experience working in a regulated environment (Medical Device, Aerospace, etc). This includes knowledge of, and experience with, applicable standards, GxP requirements and regulations. Required.
• Development experience with any or all: traditional product software, ATE, customer/product data management, product connectivity, imbedded software – required.
• Strong knowledge of system development methodologies and software program metrics is required.
• Experience with system/software Quality Engineering methods, techniques and principles required.
• Thorough understanding of GxP standards and medical device regulatory and compliance environment including: ISO 13485, 21 CFR Part 320, 21 CFR Part 11, ISO 14971, IEC 62366
• Thorough knowledge of and in-depth experience with system development configuration management and change control processes, testing (V&V), issue tracking and defect management are required.
• Experience with cyber security and data integrity requirements, methods and implementation required.
• Experience managing projects, and demonstrating project leadership abilities required. .
• Experience with a proven track record of risk identification analysis, appropriate risk mitigation w/in-depth knowledge of product/process Risk Management (FDA & ISO standards) required.
• Experience with GxP or equivalent data collection required.
• Demonstrated ability to perform “hands on” troubleshooting and problem solving.
• Demonstrated project management and project leadership abilities in virtual/cross cultural environment.
• Working knowledge of failure investigation processes, computer code static analysis methods and tools.
• Clear and effective communicator (presentation, technical writing, verbal)
Specialized Desired Q&C Competencies:
• Production and Processing Systems
• Qualification and Validation
• Product Design Support
• Quality Statistics, Data Analysis and Tools
• Product Control and Disposition
• Product Development Support
• Technical Transfer & Scale Up
• Predictive Analytics / Reliability
• Develop and lead others
• Customer focus
• Results and performance driven
• Sense urgency
• Strategic thinking
• Prudent risk taking
• Collaboration and teaming
• Self-awareness and adaptability
This position is located in Irvine, CA and may require some travel.
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