Senior Systems Engineer for Medical Device Development

1 week ago


Bengaluru, Karnataka, India Excellence and Eminence LLP Full time

We are seeking a Senior Systems Engineer with expertise in medical device development to drive the design, development, and integration of complex medical devices. The ideal candidate will have a strong understanding of regulatory standards, including ISO 13485 and FDA 21 CFR Part 820.

Key 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.


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