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System Engineer
Job description
Roles and Responsibilities: Lead the end-to-end system design of respiratory therapy devices, including hardware, firmware, and software integration. Define system-level requirements and specifications in collaboration with cross-functional teams. Evaluate the technical, regulatory, and safety implications of engineering and design change requests to ensure system integrity and compliance throughout the product lifecycle. Identify and define Critical to Safety (CTS) and Critical to Quality (CTQ) requirements, and ensure that system designs meet these requirements. Develop system architectures, interface control documents, and other technical documentation. Conduct system-level testing and verification, including test plan development and execution. Participate in design reviews and risk management activities. Troubleshoot system-level issues and provide technical support to other engineering teams. Collaborate with regulatory affairs to ensure that system designs meet regulatory requirements. Stay up-to-date with industry trends and new technologies related to respiratory therapy devices. Qualifications: Bachelor's or Master's degree in engineering or a related field. 5+ years of experience in system engineering, preferably in the medical device industry. Strong understanding of system design principles, including requirements management, risk management, and configuration management. Experience with system modeling and simulation tools. Experience with IEC 60601 and other relevant medical device standards. Excellent communication and teamwork skills. Ability to work independently and as part of a team. Experience with respiratory therapy devices is a plus. Experience with Agile development methodologies is a plus.
Required skills
teamwork
communication
industry trends
engineering
safety
hardware
troubleshooting
risk management
bachelor's degree
master's degree
system architectures
agile development methodologies
verification
regulatory affairs
technical documentation
specifications
design reviews
configuration management
regulatory
system design
new technologies
product lifecycle
firmware
software integration
requirements management
simulation tools
medical device industry
iec 60601
interface control documents
system-level requirements
design change requests
critical to safety (cts)
critical to quality (ctq)
system-level testing
respiratory therapy devices
system modeling
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Company information
- Company
- NMD Placement Consultancy
- Location
-
India, Maharashtra, Pune
India - Posted
- 8 months ago
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