Job Description: Senior Systems Engineer - Software as Medical Device (SaMD)
Position Title: Senior Systems Engineer – Medical Device Software / SaMD
Location: Bangalore
Experience: 7-12 years of experience in Systems Engineering, Medical Device Software, Digital Health, Connected Health, or Software as Medical Device (SaMD).
Position Summary
We are seeking a highly motivated and experienced Senior Systems Engineer to lead system engineering activities for Software as Medical Device (SaMD), software-enabled medical devices, and software accessories to medical devices.
The successful candidate will be responsible for translating user and stakeholder needs into system requirements, defining system architectures, managing requirements traceability, supporting risk management activities, and ensuring compliance with international medical device regulations and standards.
The role requires robust knowledge of EU MDR, US FDA medical device regulations, software lifecycle processes, and regulatory requirements applicable to software functioning as an accessory to a medical device.




Key Responsibilities
Systems Engineering
Lead systems engineering activities throughout the product lifecycle, from concept through commercialization and post-market support.
Capture, analyze, and manage: User Needs, Intended Use, Intended Purpose, System/Product Requirements, Software item and Unit-level Requirements and Regulatory Requirements
Develop and maintain: System Architecture, Functional Specifications, Interface Specifications and Requirements Traceability Matrices
Ensure end-to-end traceability between: User Needs, Design Inputs, System/Product Requirements, Software item and Unit-level Requirements, Risk Controls and Verification & Validation Activities
Work closely with software, hardware, clinical, regulatory, and quality teams throughout development.
Support development of products compliant with: EU MDR (2017/745), US FDA Medical Device Regulations and Global regulatory requirem

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