Senior Systems Engineer - Software as Medical Device (SaMD)

Job description

**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 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** Strong 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 tha