Job Title
Requirement Engineer
Job Description
- Requirements flowdown from the stake holder needs, medical standards like IEC60601
- 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 verfiable
- 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.
- Identify applicable regulatory and industry standards and ensure product can satisfy requirements of these standards.
- Update of the requirements based on the risk control measures recommended in the risk management file
- 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
- Review the design inputs and outputs to ensure quality
Must Have
- 5-7 years of experience in medical or aerospace domain with B.E. or B.Tech. in Mechanical/Electrical Engineering/ Bio medical Engineering from a reputed university.
- Hands-on experience in Requirements and risk management
- Experience with electromechanical systems with fluid circuits including fluid circuits, pumps, valves, heaters, sensors, fluidic connectors and tubing, together with a working knowledge of the supply base for fluidic components.
- Understanding of electronics concepts (microcontrollers, power supplies, programmable logic)
- Experience in requirement management, risk management(FMEA, PHA) for system, mechanical/electrical systems
- Knowledge of medical device quality and regulatory standards (ISO 13485, ISO 14791, IEC 60601, IEC 62304, etc.)
- Ability to independatly lead project / coach team memebers
- 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
Mandatory Skills
Embedded C,Embedded C++,Device Drivers
