Principal System Engineer

Job Description

Position Responsibilities:

- Provide technical leadership within cross-functional project teams to lead System Integration strategic planning to achieve project and quality goals in a systematic manner
- Investigate and resolve system issues, making improvements to address customer feedback and requests as well as leading verification and validation testing activities Lead system integration on programs with a mind toward the reduction of technical and program risks while maturing design components through mindful planning and alignment of cross-functional technical deliverables Advance system testing capabilities to evaluate product performance over varying use cases and use conditions Support leaders of system level Verification & Validation activities, documenting scope of system V&V effort, while working with product/functional engineers 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 Represent the organization as a primary contact for specific projects and initiatives; communicates with internal and external customers and vendors at various levels. May negotiate with others to reach understanding or agreement, and influence decision-making. Lead and contribute to the overall system integration and characterization efforts across a wide variety of products, including applications on smartphones and tablets, cloud-based applications, custom embedded products, labeling, etc. Typical systems incorporate wireless communications and cybersecurity solutions. Champion best practices and advanced testing techniques to obtain full test coverage with efficiency Use of automated and hands-on evaluation methods of the systems to determine maturity and reliability through a data-driven process. 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. Support human factors usability studies and other applicable system design validation related activities to ensure successful validation of user needs and intended uses along with associated risk control mitigations Identify, investigate, and resolve product issues both during product development and post launch field issues. Provide support to customers and clients for Neuromodulation systems during and after launch Review technical literature and manuals Provide guidance, coaching, and training to other employees within job area Ensure personal understanding of all quality policy/system items that are applicable. Follow all work/quality procedures to ensure quality system compliance and high-quality work Must Have: Basic Qualification Bachelor's degree in Engineering discipline and 14+ years of technical engineering professional experience or Master's degree in Engineering discipline and 12+ years of technical engineering professional experience or PhD with 10+ years of relevant experience Must Have: Desired Qualification BS in Biomedical Engineering, System Engineering, Electronics and Communication Engineering, Computer Science or related field. 2+ years software development experience. 5+ years experience in medical device industry. Knowledge of ISO and Quality System Regulation requirements. Strong verbal/written communication and influence management skills. Proven ability to accomplish critical project level objectives in a team environment. Proven ability to translate user needs into formal requirements. Experience in System Engineering discipline or use of system engineering methodologies. Nice to Have 6+ years of working with implantable medical systems Proficiency in the integration of 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) Proficiency in the integration of subsystems such as electromechanical devices, instruments, programmers, controllers, adapters and software applications Experience with Neuromodulation products and their clinical use Experience with designing for the Hardware/Firmware and wireless interfaces of electronic devices with user-centric design practices Experience in troubleshooting firmware and hardware issues using test equipment such as oscilloscopes and signal analyzers Experience with automated test systems to assess system functionality, reliability, and stability Experience with writing software and test scripts including Python, Groovy, Java, LabVIEW Experience working with and designing systems in a regulated environment (e.g., to meet ISO and Quality System Regulation requirements, including IEC-60601-1, -2, -6, IEC-62304, ISO-14971, FDA 21CFR820.30 for Class I, II and III medical systems) Experience in System Engineering discipline or use of system engineering methodologies Experience with statistics, modeling, design of experiments and data analysis Demonstrated strong verbal/written communication Demonstrated ability to take engineering data and draw system level conclusions through detailed analysis Experience working in cross-functional and team environments Familiarity with Design for Six Sigma Demonstrated ability to make decisions quickly and guide a team through complex problems

---