AI Engineer – AI-Enabled Software as a Medical Device (SaMD

Job Title: AI Engineer – AI-Enabled Software as a Medical Device (SaMD)

Independently or as member of a team; Engineer will be responsible for design, development, verification, validation, and maintenance of AI-based Software as a Medical Device (SaMD), ensuring compliance with industry standards and regulatory guidelines.

The individual should be a team player who is willing to collaborate and work in cross functional teams across geographies and cultures. Strong technical background in medical devices and applications would be preferred.

Key Responsibilities:

· Develop and maintain AI software according to EN 62304 (Medical Device Software – Software Lifecycle Processes) and ISO 13485 (Quality Management System for Medical Devices).

· Experience in implementing risk management processes in compliance with ISO 14971 (Application of Risk Management to Medical Devices).

· Experience in documentation for traceability, design controls, and verification & validation (V&V) activities as required for regulatory compliance.

· Experience in ISO 42001, AI governance frameworks, and risk management standards for AI-based medical devices.

· Experience in GMLP for medical device development principles

· Experience in data collection practices that comply with FDA guidance on AI/ML-based SaMD

· Experience in implementing robust data management systems to ensure data integrity, security, and traceability throughout the product lifecycle.

· Experience implementing continuous monitoring and post-market surveillance mechanisms to validate AI model performance in real-world clinical settings.

· Continuously improves code quality and work methodologies by interfacing with peers/cross-functional groups and analyzing activities to improve workflow and work processes.

· Willing to adopt new architecture, programming language and practices based on company future goal.

· Continuously looking for better code, design, and open to feedback.

Requirements:

· Experience: 6+ years of strong experience in design, development, verification, validation, and maintenance of AI-based Software as a Medical Device (SaMD).

· Experience in implementing risk management processes in compliance with ISO 14971 (Application of Risk Management to Medical Devices)

· Experience in documentation for traceability, design controls, and verification & validation (V&V) activities as required for regulatory compliance.

· Experience in ISO 42001, AI governance frameworks, and risk management standards for AI-based medical devices.

· Experience in GMLP for medical device development principles

· Experience in data collection practices that comply with FDA guidance on AI/ML-based SaMD

· Experience in implementing robust data management systems to ensure data integrity, security, and traceability throughout the product lifecycle.

· Experience implementing continuous monitoring and post-market surveillance

mechanisms to validate AI model performance in real-world clinical settings.

· Experience in version control, software updates, cybersecurity, and ongoing AI model improvements.

· Excellent problem-solving, project management, and leadership skills.