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Location: Pune
Company: Cyient
- As a System Engineer, you will work closely For CT/AMI team works on legacy product to ensure part and solution availability to the customer.
- Finalizes the design and integration, and writes verification plans for the developed elements and parts.
- Tests, analyses and verifies the quality of the design.
- Collaborates with software developers and systems engineers to identify and resolve issues, ensuring the integrity and reliability of system functionalities.
- Assesses test results and provides detailed reports, offering insights into system performance and recommending improvements or optimizations, ensuring compliance with industry standards and guidelines throughout the testing process.
- Experience Required: Minimum 5 to 8 years of experience in managing complex systems in the medical device industry with excellent inter disciplinary team experience and team.
- Should have experience in system engineering Requirements Engineering, Risk Management, Integration, Validation & Verification
- Should know the all the required regulatory standards like, IEC60601, ISO13485, ISO14971, EUMDR, IEC15288
- Perform decision and trade studies to identify concepts and components.
- Collaborated with cross-functional teams to conceptualize and refine product concepts.
- Defining System requirements specification and Functional requirements
- Perform integration of system elements, verification, and validation of system.
- Perform Root cause analysis and FMEA
- Manage vendor selection, testing and BOM tracking and manufacturing schedules.
- Understanding of configuration management, requirements traceability and related processes.
- Should have sound knowledge in Hardware product life cycle, Software product development cycle and Software testing life cycle.
- Experience working on a complete product development lifecycle added an advantage (project initiation, prototyping, iterative design, project completion, product release, and post-release maintenance)
- Excellent verbal and written communication skills
Specific Responsibilities Include
- Evaluation of customer/operational needs to define and coordinate system performance requirements, functional requirements, and regulatory requirements.
- Resolves cross-functional technical issues.
- Present requirement, design and/or development revision and changes to formal change boards.
Qualifications
- Bachelor’s Engineering degree, preferably in Electronics Engineering with up to 5 – 8 years of experience
- Ability to work efficiently and independently within a team. Demonstrate task ownership in a multi-functional environment; ability to serve as a domain specialist and cross-functional ownership for testing/verification is required.
- Shown problem-solving capability with excellent hands-on ability to build, debug, and modify the system and perform system failure analysis is required.
- Experience in Product Lifecycle Management systems such as Agile is preferred.Skills Required
- System Verification Engineer, Fmea, Bom Preparation
