Johnson & Johnson Careers
PRINCIPAL SYSTEMS ENGINEER, SURGICAL ROBOTICS
Requisition ID: 3288180605
Ethicon, a part of the Johnson and Johnson family of companies, is currently recruiting a Principal Systems Engineer for the development of surgical robots and instruments in their Cincinnati, Ohio location.
Our R&D team of engineers, designers and technical experts are in the forefront of technology in the medical device industry. You will be making a vital contribution to the New Product Development pipeline and transforming patient care through innovation. This is an opportunity for a key role in bringing exciting new products to market to support the J&J / Google Surgical Robotics venture. Ground-floor position to help grow and build a new J&J business unit, enabling significant professional growth.
Job Summary and Responsibilities
Work with internal and external development teams to deliver a novel surgical robot platform and advanced surgical tools.
Responsible for leading Systems Engineering activities across complex electro-mechanical surgical device programs. Integrate the work of multiple disciplines and external influences including regulatory, compliance, and ISO 13485 quality systems. Demonstrated communication and leadership skills are required as this position entails direct engagement with customers, project teams, partners, and vendors. This is a senior-level technical leadership role with commensurate responsibilities and expectations.
- Ensure implementation and integration of robotic surgical instruments provide a consistent, state-of-the-art clinical performance, including clinical outcome and user experience.
- Proactively impact the system-level definition, requirements development, integration, and testing activities to optimize development.
- Proactively engage other stakeholders to drive consensus and resolve issues in a timely fashion.
- Resolve internal and external sources of requirements (e.g. regulatory standards, risk management processes).
- Establish and impact internal tools and architecture to facilitate an effective and efficient system that enables change by creating a unified framework for evaluation and decision making.
- Manage and raise critical issues to resolve conflicts and minimize impact to program (cost, time, financial performance)
- Identify and implement necessary abstractions the simplify work with external partners
- Integrate requirements for future needs and upgrades into the process.
- Drive system validation activities in concert with external partners and other stakeholders.
- Graduate degree in an appropriate engineering/technical or clinical field (Biomedical Engineering, Life-sciences or Clinical practice)
- Minimum 10 years experience in a medical-device or clinical environment; at least 5 years within a regulated medical-device environment.
- Demonstrated effectiveness in leading, aligning, and collaborating across organizational boundaries (e.g. project teams, functions, and partner organizations) without direct authority
- Thorough understanding of leading product or system design through verification and validation, including extensive direct customer contact.
- Working understanding and knowledge of medical device risk management activities, e.g. Hazard Analyses, FTA, and FMEA
- Thorough understanding of clinical effectiveness. its evaluation and verification.
- Terminal degree or clinical qualifications
- Working experience in surgical devices, procedures and direct interaction of clinical customers.
This position is based on Cincinnati, Ohio, and may involve up to 30% travel.
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