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Sr Systems Engineer

Bengaluru, KA
Job Code:
  • Medical
  • Manufacturing & Production
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Job Details

Work with customer-facing team members (human factors and voice-of-customer specialists) to understand user needs and convert them into high-level product specifications. Develop detailed technical requirements, and ensure accurate flow-down to sub-system requirements, design implementation. Coordinate the team effort of interdisciplinary engineers (electronics, mechanical, firmware, and chemical) for design of the product. Participate and provide technical expertise for technical tradeoff decision making. Define Use case scenarios and system behaviors for the use scenario. Perform risk assessment for the product and develop risk mitigation strategies. Identify applicable regulatory and industry standards and ensure product can satisfy requirements of these standards. Develop design verification/design characterization/ validation plans; executes test plans and document test results. Apply Six-Sigma knowhow where applicable. Work with quality/reliability engineering to identify and minimize sources of technical and practical risk, and ensure the product meets medical device-related safety standards. Work with clinical and regulatory groups to ensure the product is approved for commercial use. Basic Qualifications Bachelor of Engineering in Electronics / Mechanical / Biomedical Engg from a reputed university 8+ years of total work experience in design and development of multidisciplinary technical products (biomedical, electromechanical, hardware-software, etc.) Experience working in all phases of the product development lifecycle (conceptualization, prototyping, design completion, commercial release, and cost-down/continuous improvement) 3+ years experience in the healthcare domain, with knowledge of medical device-related standards such as ISO 13485, US FDA s 21 CFR 820, IEC 60601, etc. OR in a regulated industry such as aerospace or automotive Demonstrated ability to complete complex technical tasks on time, by providing strong technical leadership and guiding/coaching early-career engineers Excellent verbal and written communication skills, strong critical thinking, negotiation and influencing skills Experience in applying Six-Sigma methodologies. Expertise with data analysis tools such as Excel, Minitab, Crystal Ball, etc. Ability to work with a cross-functional and cross-cultural global team, and participate in early morning and/or late evening conference calls Desired/Preferred Qualifications Master s degree in Electronics/ Mechanical/Biomedical/ Systems Engg, or INCOSE certification Fundamental understanding of multiple technical fields. E.g. if you are a mechanical engineer, it would be a bonus for you to have knowledge of electrical engineering, or biomedical engineering concepts (human anatomy, diseases, diagnostics, therapy) Understanding of fluid circuits and flow control mechanisms (pumps, valves, heaters, sensors, etc.) Lean or Six-Sigma Green Belt or Black Belt certification inclusive of development methodologies like Design of experiments Understanding of reliability testing concepts
Degree: MCA/ PGDCA

Additional Degree: BE/ B.Tech (Engineering)

Experience: 8-13


Application Programming | Software Engineer | System Analyst/Tech Architect
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