J&J Family of Companies Senior Systems Engineer Risk Management in Santa Clara, California
Robotics & Digital Solutions, part of the Johnson & Johnson family of companies, is recruiting for a Senior Systems Engineer, located Santa Clara, CA.
Robotics & Digital Solutions is part of Ethicon, Inc., a global leader in surgery with products and solutions found in almost every operating room around the world. Ethicon has made significant contributions to surgery for more than 100 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 robotics, digital solutions, 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 Senior Systems Engineer will have a role in the risk management of J&J’s most advanced robotic surgical system. The engineer will apply an interdisciplinary systems engineering approach to risk management, requirements management, and safety architecture. In addition, the Engineer will be expected to contribute significantly to establishing standard procedures and good engineering practices of the above activities in the team, to meet all safety and regulatory compliance. The successful candidate will be able to lead the resolution of risk problems that are by nature, highly unstructured and uncertain.
Core Job Responsibilities
Work with HW, SW, systems, quality, and clinical engineering teams to lead risk analysis activities at a system level, identifying proper risk mitigation solutions to the complex robotic surgical system and subsystems
Work across engineering teams to create, manage, and track system- and subsystem-levels of risk mitigation requirements and specifications
Develop new processes to identify and manage risk for a complex robotic surgical system
Propose and lead new safety related design input requirements
Ensure systems design and documentation meet all safety and regulatory compliance
Contribute significantly to establishing the best engineering practices in the full product development cycle for the entire team
Other related duties as may be assigned
Bachelor’s degree in Electrical, Mechanical, Systems Engineering or related Engineering degree is required. Advanced degree in systems engineering, robotics, mechanical engineering, mechatronics, or, other related field is preferred
5+ years of related work experience with a Bachelor’s, or, equivalent combination of experience and higher education is required
Experience with medical device robotics is preferred
Experience through full product development cycle of complex electromechanical systems, from initial concept to release to market is required
Strong understanding of systems, mechatronics, and software integration is required
Experience supporting requirement development is preferred
Strong experience with Risk Management and ISO 14971 or equivalent federally regulated standard(s) is required
Expertise in design and development processes that conform to standards, including IEC 60601, IEC 62304, etc., and ability to work in a regulated environment in compliance to ISO 13485 and 21 CFR 82 is highly preferred
Demonstrated technical leadership and issue ownership; proven ability of analytical problem solving, and troubleshooting is required
Ability to travel up to 10%, international or domestic is required
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-California-Santa Clara-5490 Great America Pkwy
Verb Surgical Inc. (6270)