System Validation Engineer Medical Devices (Fresher to 1 year)

Company Description

SARACA is a global engineering R&D services company serving 25+ Fortune 500 clients across industries such as MedTech, Aerospace, Automotive, and more. As an ISO 13485-certified organization, we specialize in designing and developing innovative medical devices with expertise in embedded software, UI/UX, mechanical systems, and product testing. Our proficiency extends to IEC 62304, EU MDR, and scientific writings in MedTech. With over 400 skilled engineers and management consultants, SARACA delivers impactful solutions globally, fostering innovation and learning within its diverse team. We are committed to driving success and growth for our clients while maintaining an inclusive and welcoming work environment.

Role Description

As a System Test Engineer, you will be responsible for end-to-end system testing, verifying system and sub-system requirements, and creating DHF deliverables such as Test Procedures and Test Reports. You will collaborate across engineering teams to ensure robust system validation and compliance with regulatory standards.

Key Responsibilities

• Execute System Verification & Validation (V&V) activities for robotic systems
• Develop and execute comprehensive test strategies aligned with product requirements
• Author verification plans, test protocols, test cases, traceability matrices, and summary reports
• Ensure traceability between requirements, test protocols, and results
• Coordinate lab resources (equipment, personnel, and space) for testing
• Identify, report, and track defects using tools like JIRA; support root cause analysis
• Contribute to Agile practices including TDD, BDD, and automation initiatives
• Collaborate with cross-functional teams (Systems, Software, Hardware)
• Ensure compliance with FDA, EU MDR, and ISO 13485 standards

Qualifications

• BS/MS in Electrical, Computer, Software, Biomedical Engineering, or Computer Science
• 0–1 year of experience in the medical device domain (Freshers are welcome)
• Strong communication and interpersonal skills