Responsible for leading Systems Engineering activities across complex electro-mechanical surgical programs, with a concentration on electrical and software elements including their architecture, design and verification.
Integrate the work of multiple technical disciplines to an appropriate safety architecture while assuring the final product design is verifiably safe and effective through-out its life-cycle. Demonstrated technical leadership and communications skills are required.
- Lead the architectural refinement of the safety architecture for large systems and assure their clear and explicit definition, documenting critical and essential performance.
- Ensure adequate modularity by defining technical interface boundaries between complex sub-systems and products, enabling future platforms growth. Allocation and decompose requirements across subsystems.
- Guide efficient development, implementation, and integration to assure successful verification and product launch.
- In concert with design teams, provide expert guidance on technical management of risks throughout the system lifecycle.
- Enhance efficiency of the solution by managing the partitioning of system functions across reusable capital systems and disposable surgical tools.
- Improve serviceability and reliability of the system through guidance provided on the partitioning of the overall design while establishing design specific requirements.
- Identify, manage and resolve critical issues to minimize impact to program (cost, time, financial performance)
- Perform appropriate analysis to ensure the documented architecture is safe and effective.
- Ensure product & system technical specifications and requirements are verifiable while contributing the system verification and validation.
- Generate and present technical material necessary for the comprehension and understanding of stakeholders at all levels of the organization, exhibiting patience in conveying new approaches
- BS/MS in a technical discipline (Engineering or Computer Science preferred)
- Minimum 10 years experience in a New Product Development environment; at least 5 years in a Systems Engineering or architectural role.
- Substantial experience with large systems development, preferably electro-mechanical, safety critical and/or fault tolerant designs.
- Strong abstraction and conceptualization skills with working knowledge of modeling and formal analysis.
- Thorough working knowledge of requirements management
- Thorough working knowledge of configuration management and revision control across the life-cycle of long-lived capital equipment and related software
- Thorough understanding and working knowledge of Product Risk Management processes and experience in leading safety risk management activities, e.g. Hazard Analyses, FTA, and FMEA
- Experience in leading the development of complex multi-disciplinary product/system architectures and system interfaces
- Thorough understanding of Design Verification and validation activities
- Demonstrated effectiveness in collaborating across organizational boundaries without direct authority Desired Qualifications
- Experience in obtaining product safety certification
- Experience in and working knowledge of safety critical/fault tolerant software development across their life-cycles
- Previous experience with medical/surgical devices and/or procedures
- This position is based on Cincinnati, Ohio, and may involve up to 20% travel.
Requisition ID: 1977170524