Robotics & Digital Solutions, part of the Johnson & Johnson family of companies, is recruiting for a Manager of Systems Risk Management, 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 Manager of Systems Risk Management will lead the systems risk management of J&J’s most advanced robotic surgical system. The manager will apply dynamic leadership techniques coupled with an interdisciplinary systems engineering approach to risk management, requirements management, and safety architecture to manage a team performing system-level risk analysis. In addition, the manager will be expected to establish 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 product risk analysis questions that are, by nature, highly unstructured and uncertain.
Core Job Responsibilities
- Work with Hardware, Software, Systems, Quality, and Clinical Engineering teams to lead risk analysis activities at a system level, identifying risk mitigation solutions to the complex robotic surgical system and subsystems
- Direct managerial oversight to a team of systems engineers focusing on systems risk analysis
- Collaborate 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
- 7+ years of related work experience or equivalent combination of experience and higher education
- 1+ years of direct people leadership
- 1+ years of strong experience with Risk Management and ISO 14971 or equivalent federally regulated standard(s)
- Demonstrated technical leadership and issue ownership; proven track record of analytical problem solving and troubleshooting
- Experience through full product development cycle of complex electromechanical systems, from initial concept to release to market
- Ability to travel up to 10%, international or domestic
- Advanced degree in Systems Engineering, Robotics, Mechanical Engineering, Mechatronics, or other related field
- 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
- Experience with medical device robotics
- Experience supporting requirement development
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.