Location
Bangalore | India
Job description
We are looking for a Lead systems engineer who will work on capturing system requirements, concept design, system modelling, risk analysis, system. Given the entrepreneurial nature of MIDC, this person will have to perform hands-on work in the mechanical/systems.
- 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.
- Discuss with system verification engineers to ensure that the system requirements are adequate and verifiable
- Coordinate the team effort of interdisciplinary engineers (electronics, mechanical, firmware, and chemical) for design of the product. Review the design analysis results (thermal, vibration, CFD etc) and provide technical expertise for technical tradeoff decision making.
- Define the use condition and use cases to develop the system features. Define the logics and provide inputs to the software team for implementing the use cases.
- Perform risk assessment for the product and develop risk mitigation strategies.
- Build system simulation models to predict fluid circuit behavior and provide required inputs to the matlab Simulink modelling of the system.
- Make verification strategy covering all the requirements, considering 1-to-1, 1-to-many and many-to-1 mapping of requirements and protocols
- Create design verification test plans and reports to assure that the design meets requirements.
- Make protocols for system / sub-system requirement, considering the use conditions, ensuring the quality and adequacy
- Identify suitable equipment's for carrying-out verification
- Ensuring availability of equipment's with calibration as needed
- Experience in Test method validation.
- Experience in performing GRR/MSA studies.
- Good knowledge on statistical analysis of data like Ppk, Cpk analysis.
- Identify applicable regulatory and industry standards and ensure product can satisfy requirements of these standards.
- Work with operations and supply chain to ensure manufacturability of the product and identify contract manufacturers who can build the product. Participate in design transfer activities.
- 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
Must Have - 4+ years of experience in medical or aerospace or automotive domain with B.E. or B.Tech. in Electrical Engineering from a reputed university.
- Experience with electromechanical design and optimization of fluid circuits including fluid mechanics, pumps, valves, heaters, sensors, fluidic connectors and tubing, together with a working knowledge of the supply base for fluidic components.
- Basic understanding of electronics concepts (microcontrollers, power supplies, programmable logic)
- Ability to independently lead project / coach team members
- Good verbal/written communication skills. Ability to produce good quality documentation.
- Ability to work in a global environment and interact with various internal and external stake holders.
- Expertise with Microsoft Project, Excel, Word and PowerPoint
Desired / Preferred Qualifications - Experience in the healthcare domain, with knowledge of medical device-related standards such as ISO 13485, US FDA's 21 CFR 820, IEC 60601, IEC 60068 and ISO 10993
- Basic understanding of biomedical concepts (human anatomy, disease, diagnostics, therapies)
- Working knowledge of dialysis therapy
- Basic understanding of biomedical concepts (human anatomy, disease, diagnostics, therapies)
- Basic understanding of chemistry concepts (working knowledge of water purification technologies, including filtration, reverse osmosis, carbon beds, and ion exchange processes
Powered by JazzHR
w0XkAuem4D
Job tags
Salary
