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Must have Bachelor’s degree in Engineering discipline, preferred M.Tech/PhD
Must have overall 8-12years of experience 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 Medical 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, modelling, 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
Global leader in medical technology and healthcare solutions.
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