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System Engineer-Medical Devices

2 months ago

bangalore, India Excellence and Eminence LLP Full time
Job Description
We are looking for a Technical Lead Systems Engineer to drive the design, development, and integration of complex medical devices, ensuring regulatory compliance and leading cross-functional teams.
Key Skills
Systems engineering, medical device development, system integration, risk management, ISO 13485 and FDA 21 CFR Part 820.
Responsibilities
- Lead systems engineering efforts for medical device development from concept to commercialization. 
- Develop and manage system requirements, architecture, and design documentation. 
- Oversee hardware, software, and assay component integration into cohesive systems. 
- Conduct design reviews, risk assessments, and ensure compliance with regulatory standards. 
- Provide technical leadership and mentorship to junior engineers.
Requirements - Bachelor’s/Master’s in Systems Engineering, Biomedical Engineering, Electrical Engineering, or related field. 
- 8-12 years of experience in systems engineering, with 3+ years in medical device development. 
- Strong understanding of design control, risk management, and regulatory standards. 
- Proven experience with system integration and troubleshooting complex electromechanical systems. 
- Excellent project management, leadership, and communication skills.
Benefits About the Customer
You will be working with a trusted global product engineering and lifecycle services partner to the world’s most recognized companies in the Aero Engines, Aerospace & Defense, Hi-Tech, Transportation (Auto and Rail), Power and Industrial, Oil & Gas, and Medical Devices industries. With 12K+ experts, and a global presence in 73 locations across 15 countries, it believes that it is at the forefront of the convergence of mechanical, electronics, software, and digital engineering innovations to enable solutions for a safer, cleaner world. A Strong Process based organization Certified for CMMI L5 and multiple other certifications of the process and one of the few organizations which are ranked as best place to work.
Requirements
Systems engineering, medical device development, system integration, risk management, ISO 13485 and FDA 21 CFR Part 820.