J&J Family of Companies Principal Systems Verification Engineer in Santa Clara, California
Ethicon, a member of the Johnson & Johnson family of companies is recruiting for a Principal Systems Verification Engineer, R&D Advanced Imaging, located in Cincinnati, Ohio or Santa Clara, California with possible flexibility on location.
Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com .
The Principal Systems Verification Engineer is a critical team member for our Advanced Imaging product pipeline, and a key contributor for new product development programs. This represents an excellent opportunity if you are inspired by building groundbreaking surgical capabilities and working in a multi-functional environment!
The Principal Systems Verification Engineer will provide technical leadership and execution for the test engineering and verification and validation (V&V) strategy for the Advanced Imaging system. The individual should have strong communication skills as they will work closely with systems engineering, design and development engineering, clinical engineering, and quality engineering to develop and ensure the testability of requirements, while developing and validating test methods that will demonstrate the safety and effectiveness of the Advanced Imaging system.
Main areas of responsibility:
Provides technical leadership and direction to team members responsible for system V&V engineering activities via an indirect authority structure.
Leads the development and implementation of hardware and software V&V strategy throughout product lifecycle.
Leads the planning, development, and execution of system V&V objectives, e.g. test plans, test protocols, test cases, test reports.
Partners closely with developers and incorporates test planning into design and development phases and is key contributor to the development of system requirements, architecture, and design.
Supports the team in investigations for identifying the root cause of failures and definition and implementation of control measures.
Creates opportunities to automate testing, optimize test processes, lead develop of integration, regression, and stress tests using industry standard tools.
Manages third party verification resources and activities.
Participates in and/or leads design reviews.
Assures compliance to the product development process and Quality Management System.
Assures good documentation practices are followed in the V&V process.
Supports the development of more junior staff and advises management on technical matters.
A minimum of a bachelor’s degree in Engineering is required. An advanced degree is preferred.
Minimum of 8 years’ relevant experience
Significant experience with the following:
New product development experience in a regulated environment,
Experience and demonstrated accomplishments leading test engineering and V&V under Agile development methodology.
Excellent understanding of requirements management, configuration management, product hardware and software V&V, defect management and risk analysis.
Experience designing test strategies based on requirements, architecture, and design.
Experience in test method development and validation, including statistical techniques.
Excellent organizational skills including attention to detail and multi-tasking skills.
Demonstrated results in technical leadership, development and mentoring, and leading a team across multiple sites.
Experience with industry standard software development and automation tools (Python, JIRA, Jenkins, Git, Docker, etc).
Strong communication skills, with demonstrated results collaborating with both leadership and technical and non-technical team members.
Position will be located in Cincinnati, OH or Santa Clara, CA and may require up to 30% Domestic and international travel.
Understanding of surgery, surgical procedures, and the design and application of surgical devices, as well as the quality system and regulatory environment.
Medical Device experience is strongly preferred.
Experience developing complex medical capital equipment, most preferably minimally invasive surgical visualization systems.
Experience with Continuous Integration/Continuous Delivery (CI/CD).
Experience with building test automation capabilities from ground up.
Prior people management experience with direct supervision
Demonstrated working knowledge of ISO 14971, 21 CFR 820, Design Controls, IEC 60601, IEC 62304 and other relevant medical device standards.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
United States-Ohio-Cincinnati-4545 Creek Road
North America-United States, North America-United States-California-Santa Clara
Ethicon Endo Surgery Inc (6041)
J&J Family of Companies
- J&J Family of Companies Jobs