Principal Systems Engineer

1 week ago

Hyderabad, Telangana, India Medtronic Full time

Careers that Change LivesBe a part of the Medtronic Engineering and Innovation center (MEIC) in Hyderabad by applying your skills to thegrowth, development and sustaining efforts of Medical Devices products within the center.

This position will supportthe Systems Integration organization in the definition, design and development of complex medical device systemsfor the treatment of conditions related to the central nervous system.

Typical system designs involve complexelectronic circuits, wireless communication, batteries and a mix of consumer and medical technologies. Systemdesigns to be designed with the user in mind to provide innovative solutions in the marketplace.

The Engineering R&D function at MEIC, Hyderabad encompasses design, development and verification activitiesduring New Product Development (NPD) and Sustaining phases of the product development cycle for the GlobalBusiness Unit (GBU)s.

Neuroscience Group develops life-restoring therapies and healthcare solutions that span the care continuum;integrating technologies and applying clinical and economic evidence to increase patient access, improve efficiencyof procedures and deliver successful patient outcomes.

You'll always have new challenges pursuing ideas that are exciting and innovative. Build out the future of digitalhealthcare, data analytics as well as adaptive and closed-loop neuromodulation. Think critically about healthcareproblems and/or opportunities to advance science faster than others. Do research on improving the healthcare ofmillions.

Position Responsibilities:

  • Provide technical leadership within cross-functional project teams to lead System Integration strategicplanning to achieve project and quality goals in a systematic manner
  • Investigate and resolve system issues, making improvements to address customer feedback and requests aswell as leading verification and validation testing activities
  • Lead system integration on programs with a mind toward the reduction of technical and program risks whilematuring design components through mindful planning and alignment of cross-functional technicaldeliverables
  • Advance system testing capabilities to evaluate product performance over varying use cases and useconditions
  • Support leaders of system level Verification & Validation activities, documenting scope of system V&Veffort, while working with product/functional engineers to ensure proper and complete coverage along withconfirming 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 withinternal and external customers and vendors at various levels. May negotiate with others to reachunderstanding or agreement, and influence decision-making.
  • Lead and contribute to the overall system integration and characterization efforts across a wide variety ofproducts, including applications on smartphones and tablets, cloud-based applications, custom embeddedproducts, 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 reliabilitythrough a data-driven process.
  • Review requirements for implantable medical device systems for testability and completeness that meet theexpectations 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, establishingperformance 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 toensure 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 fieldissues.
  • 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/qualityprocedures 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, ComputerScience 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 asimplantable medical devices as well as information systems (defense or aerospace industry experiencedindividuals 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 withuser-centric design practices
  • Experience in troubleshooting firmware and hardware issues using test equipment such as oscilloscopes andsignal 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 QualitySystem Regulation requirements, including IEC , -2, -6, IEC-62304, ISO-14971, FDA 21CFR820.30for 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

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