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Staff Software Quality Engineer- NPD/Capital Equipment
Requisition ID: 6249180316
Johnson & Johnson Vision Care, a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Software Quality Engineer- NPD/Capital Equipment to be located in Milpitas, CA.
Johnson & Johnson Vision (JJV), is a worldwide company with operations in the United States, Japan, Latin America, Asia-Pacific and Europe/Middle East/Africa regions. Research, innovation and new-product development are the focus of our organization. Since we introduced soft disposable contact lenses in 1988, and through the acquisition of Abbott Medical Optics in 2017, no other manufacturer has matched the aggressive expansion of our wide-ranging Surgical Vision (Cataracts and Lasik portfolio) and Vision Care (ACUVUE and Consumer Eye Health solutions) family of products. Our associates around the world are committed to expanding the J&J Vision brands brand, and fortifying our position as the worldwide leader in total eye healthcare solutions.
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
You, the Staff Software Quality Engineer- NPD/Capital Equipment provides quality and technical leadership to ensure new medical devices (Capital Equipment) meet their intended use.
You, the Staff Software Quality Engineer- NPD/Capital Equipment provides:
- Quality leadership on new product project teams to ensure that medical devices and stand-alone software systems are being designed and validated to meet their intended use.
- Subject matter expertise in requirements gathering, facilitating software risk assessments, defining test strategies, and guiding project teams on design controls and defect analysis.
You, the Staff Software Quality Engineer- NPD/Capital Equipment will:
- Partner with R&D to define the white-box testing and black-box testing strategy.
- Ensure effective risk management by working with R&D to define risk control measures.
- Lead/manage/conduct SW relevant product validation activities on projects.
- Develop testing strategies based on requirements and designs.
- Create/review and/or approves product/ equipment/ software validation documentation.
- Conduct and drive CAPA root cause investigations.
- Refine the Design Controls and other supporting processes.
- Review test case execution results and manage defects.
- Perform other related duties as assigned by management.
- Support the development of more junior staff and advise management on technical matters.
- Proactively examine processes to identify areas for review, change, or elimination.
- A Bachelor’s Degree in Computer Sciences, Software Engineering or other related disciplines is required.
- A Master’s degree is preferred.
- A minimum 6 years of work experience supporting the testing of systems that are controlled by software.
- Experience working in the Medical Device industry is required.
- Excellent understanding of requirements management, configuration management, Product Software V&V, defect management and software risk analysis is required.
- The ability to document system requirements, and understand system architecture and software designs is required.
- Experience designing test strategies based on software architecture, requirements and design is required.
- Programming background is preferred.
- Knowledge of ISO 14971, 21 CFR 820, and 21 CFR 210 and 211 is required.
- Excellent communication, interpersonal and leadership skills is required.
- This position will be located in Milpitas, CA and may require up to 10% domestic and/or international travel.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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