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.
Ethicon offers a broad range of products, platforms and technologies—including sutures, surgical staplers, clip appliers, trocars and synthetic mesh devices—that are used in a wide variety of minimally invasive and open surgical procedures. Specialties include support for treatment of colorectal and thoracic conditions, women’s health conditions, hernias, cancer and obesity. Ethicon, Inc. based in Somerville, New Jersey, was founded more than 80 years ago as a pioneer in suture development and manufacturing, helping to transform the safety and effectiveness of open surgery. Ethicon Endo-Surgery, Inc. was created 20 years ago in Cincinnati, Ohio, developing innovative devices that have driven the revolutionary shift from open to minimally invasive surgery that continues to lead the industry today.
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. Our Design Engineer executes specific & general assignments/projects that provide innovative, functional, cost effective & validated product designs in a team based environment. This is an opportunity for a key role in bringing exciting new products to market to support the J&J / Google robotics venture. Ground-floor position to help grow and build a new J&J business unit, enabling significant professional growth.
The Principal Systems Engineer will:
- Work with internal and external development teams to deliver a novel surgical robot platform and advanced surgical tools
- Be responsible for leading Systems Engineering activities across complex electro-mechanical surgical device programs
- Using a broad, interdisciplinary background and demonstrated competencies as described below, integrate the work of multiple technical disciplines, as well as external influences on medical device development such as regulatory, compliance, and ISO 13485 quality systems.
- Strong communication and leadership skills are required as this position will entail direct engagement with customers, project teams, partners, and vendors. This is a senior-level technical leadership role with commensurate responsibilities and expectations
- Lead system-level definition, development, implementation, integration, and launch of complex multi-disciplinary surgical instruments for a new surgical robotic platform to deliver a valuable product to the end customer and meet the needs of multiple stakeholders
- Collaborate with users and other stakeholders to formalize their needs and maintain formal systems for translating and maintaining the corresponding requirements
- Proactively determine and manage other sources of systems requirements (e.g. regulatory standards, risk management processes, relevant industry standards, and business requirements) throughout the system lifecycle, engaging subsystem teams as needed
- Define and manage the technical interfaces between complex surgical robotic platforms and current and future advanced surgical instruments
- Lead the system architecture by managing requirements and partitioning of system, including between reusable capital systems and disposable / resposable surgical tools.
- Manage and raise critical issues to resolve conflicts and minimize impact to program (cost, time, financial performance)
- Partition systems into subsystems. Formally translate and manage apportionment of requirements and functionality among subsystems
- Ensure appropriate change control processes and disciplines, ensuring that changes are appropriately reflected throughout system and subsystems
- Allocate and integrate requirements for multiple disciplines (potentially including electronics, software, firmware, optics, ID/HF, etc.) while considering future needs for connectivity and upgrades (e.g. interconnectivity with hospital systems)
- Lead and partner closely with all other system and subsystem teams to optimize the output of the system for the customer
- Manage the resolution of cross-functional and cross-platform issues, tradeoffs, and risk in accordance with system objectives
- Manage the integration and verification of subsystems in accordance with program requirements and design. Own the validation of the system against customer requirements
- A BS/MS in an engineering discipline is required (Mechanical, Biomedical, Electrical preferred)
- A Minimum of 10 years overall engineering experience in an interdisciplinary product development environment is required with at least 5 years of this experience in an SE role within an FDA-regulated environment
- Demonstrated effectiveness in leading, aligning, and collaborating across organizational boundaries is (e.g. project teams, functions, and partner organizations) without direct authority is required
- Thorough understanding of and leading requirements management; from development through verification and validation, including extensive direct customer contact; experience with requirements management tools is required
- Thorough understanding and working knowledge of ISO 14971:2012; experience in leading safety risk management activities, e.g. Hazard Analyses, FTA, and FMEA is required
- Experience in leading the development of complex multi-disciplinary product/system architectures is required
- Thorough understanding of safety compliance process (product safety marks) is required
- Thorough understanding of and leading Design Verification activities is required
- Experience in conduct and support of Design Validation activities is required
- Experience in obtaining device safety marks (e.g. CSA, UL) is preferred
- Experience in and working knowledge of IEC 62304 Medical Device Software – Software Life Cycles is desired
- Membership in professional organizations, e.g. AAMI, RAPS, IEEE, INCOSE is preferred
- Understanding of surgery, surgical procedures, and the design and application of surgical devices is preferred
- This position is based in Cincinnati, OH and may require up to 30% domestic travel
Ethicon Endo Surgery Inc (6041)Job Function
R&D Engineering (R&D)Requisition ID