: 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 strong 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 requirements for medical device software.

Contribute to regulatory strategy, product classification, and technical documentation.

Software as Medical Device (SaMD)





Define and manage system requirements for Software as Medical Device products.

Support software development lifecycle activities aligned with: IEC 62304

IMDRF SaMD framework

FDA Software Guidance

Collaborate with software teams on: Requirements decomposition

Architecture reviews

Integration activities

Verification and Validation planning

Assess system impacts of software changes and releases.

Medical Device Accessory Software Expertise

Evaluate software products intended to function as accessories to medical devices.

Understand regulatory implications of software that: Controls medical devices

Drives device functionality

Displays or transmits medical device data

Enables intended use of a medical device

Supports clinical decision-making related to device operation

Support classification and documentation activities for software accessories under EU MDR and FDA frameworks.

Define system requirements ensuring compliance for software accessory functionality.

Risk Management

Lead and participate in risk management activities in accordance with: ISO 14971

EU MDR Risk Management requirements

Ensure traceability between hazards, mitigations, system requirements, and verification evidence.

Verification & Validation

Define system-level verification and validation strategies.

Create, Review: Test Protocols, Test Plans.

Validation

Reports and Traceability Matrices

Support integration, system, usability, and clinical validation activities.

Ensure objective evidence meets regulatory and quality requirements.

Quality & Standards Compliance

Ensure compliance with: ISO 13485

IEC 62304

ISO 14971

IEC 62366

IEC 82304-1

FDA Design Controls

EU MDR Requirements

Support CAPA, change management, and continuous improvement initiatives.

Required Qualifications

Education





Bachelor's or Master's degree in: Systems Engineering, Biomedical Engineering or equivalent discipline, Software Engineering.

Experience

7-12 years of experience in systems engineering for regulated products.

Minimum 5 years working with: Medical Devices

Digital Health Products

Software as Medical Device (SaMD)

Experience supporting products regulated under: EU MDR

US FDA

Experience working in Agile and/or V-model development environments.

Experience with requirements management and traceability tools.

Required Technical Knowledge

Robust understanding of

EU MDR 2017/745

FDA Medical Device Regulations

Software as Medical Device (SaMD)

Medical Device Accessory Software

IEC 62304 Software Lifecycle Processes

ISO 14971 Risk Management

ISO 13485 Quality Management Systems

IEC 62366 Usability Engineering

IEC 82304-1 Health Software

Cybersecurity requirements for medical devices

Systems Engineering methodologies

Design Controls and Product Lifecycle Management

Preferred Skills

Experience with medical imaging, diagnostics, remote patient monitoring, digital therapeutics, AI/ML-enabled medical software, or connected medical devices.

Experience with requirements management tools such as: Azure DevOps

Knowledge of cloud-based healthcare software architectures.

Experience interacting with Regulatory Affairs, Quality Assurance, and Notified Bodies.

Key Competencies

Systems Thinking

Requirements Engineering

Regulatory Compliance

Risk Management

Technical Documentation

Cross-functional Collaboration

Problem Solving

Stakeholder Management

Root Cause Analysis

Communication and Leadership Skills

Success Profile The ideal candidate will serve as the technical systems engineering lead for medical device software products, ensuring that system design, requirements management, risk controls, verification, and validation activities comply with EU MDR, US FDA, and applicable standards for Software as Medical Device (SaMD) and Medical Device Accessory Software, enabling successful product development and global market access.

📌 Senior Systems Engineer - Software as Medical Device (SaMD) (Bengaluru)
🏢 Cyient
📍 Bengaluru