A Day in the LifeResponsibilities may include the following and other duties may be assigned.
- System Requirements Specifications Creation, Analysis, Documentation and Review
- Investigate and resolve product / system issues, making improvements to address the issues.
- Product / System testing capabilities to evaluate product performance over varying use cases and use conditions
- Support leaders of system level to ensure proper and complete coverage along with confirming that the behavior of the system meets the requirements as well as user needs and intended uses
- Holding accountability for the product related requirements.
- Champion best practices and advanced testing techniques to obtain full test coverage with efficiency
- Review requirements for implantable medical device systems for testability and completeness that meet the expectations and uses of the customer, regulatory agencies, standards, etc.
- Ensure customer needs, use cases and user workflows are translated into specific, well-written requirements, design features and associated integration test cases.
- Participate in technical architecture activities for system definition, including partitioning, establishing performance measures, and well-defined interfaces to ensure high quality systems
- Perform/participate in Risk Analysis activities, such as FMEA, and Hazard Analysis activities for systems, features, and implementations with the intent to eliminate or mitigate the risks in the identified scenarios.
- Identify, investigate, and resolve product issues.
- Review technical literature and manuals
Required Knowledge and Experience
- 8+ years Systems / Product development experience.
- Bachelor s degree in Engineering discipline and 8+ years of technical engineering professional experience OR
- Master s degree in Engineering discipline and 6+ years of technical engineering professional experience
- Strong verbal/written communication and influence management skills.
- Ability to accomplish critical project level objectives in a team environment.
- Knowledge in System Engineering discipline or use of system engineering methodologies.
- Familiarity with creating System Requirements
- Strong verbal/written communication
- Working in cross-functional and team environments
NICE TO HAVE:
- Familiarity in the complex systems, which may include biomedical systems such as implantable medical devices as well as information systems (defense or aerospace industry experienced individuals encouraged to apply as well)
- Familiarity in the subsystems such as electromechanical devices, instruments, programmers, controllers, adapters and software applications
- Familiarity with Hardware/Product/ Systems
- Familiarity with Product Development Life Cycle
