Agiliad

Test Engineer - Medical Devices (Cardiovascular Domain)
Job Title:
Test Engineer / Senior Test Engineer - Medical Devices (Cardiovascular)
Experience: 5-10 Years
Location:
Boston, MA, USA
Job Summary:
We are looking for a highly skilled Test Engineer with strong experience in the Medical Devices domain, specifically in Cardiovascular/Cardiac devices. The candidate will be responsible for Verification & Validation (V&V), Design Verification Testing (DVT), reliability testing, and system-level validation of complex electro-mechanical medical devices.
The ideal candidate should have hands-on experience with test instrumentation, data acquisition systems, embedded interfaces, and regulatory-driven medical device testing in an FDA-regulated environment.
Key Responsibilities:

• Understand device design, system architecture, and core technologies to support effective test method development for cardiovascular medical devices.
• Generate and execute test plans, protocols, and procedures derived from product functional requirements, feasibility studies, and risk analysis activities.
• Lead and conduct Design Verification Testing (DVT), including extended reliability and stress testing activities.
• Develop detailed test protocols, procedures, traceability documentation, and final test reports.
• Select, configure, and validate test instrumentation, fixtures, and data acquisition systems as required by testing standards and product requirements.
• Configure and operate test fixtures, sensors, and instrumentation for electrical, mechanical, pressure, temperature, and flow-based testing.
• Perform troubleshooting and analysis using oscilloscopes, multi-meters, function generators, power supplies, and pressure/flow measurement transducers.
• Work with communication interfaces such as UART, USB, and CAN for device-level validation and debugging.
• Perform system, integration, functional, regression, and reliability testing for cardiovascular and medical device applications.
• Train engineers and technicians on testing methodologies, protocols, and lab equipment usage.
• Maintain accurate documentation, test records, and traceability matrices in compliance with FDA, ISO 13485, and IEC 60601 standards.
• Collaborate closely with cross-functional teams including R&D, firmware, hardware, systems engineering, and quality assurance teams.

Required Skills:

• Strong experience in Medical Devices domain with exposure to Cardiovascular/Cardiac devices.
• Hands-on experience in Verification & Validation (V&V) and Design Verification Testing (DVT).
• Knowledge of FDA-regulated medical device development lifecycle and design controls.
• Experience with reliability testing and system-level testing.
• Experience with test instrumentation and lab equipment.
• Knowledge of communication interfaces such as UART, USB, and CAN.
• Basic scripting/programming experience in Python.
• Strong debugging, analytical, and problem-solving skills.
• Understanding of IEC 60601, ISO 13485, and medical device compliance standards.

Qualifications:

• BS/MS in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Software Engineering, or related field.
• Minimum 5+ years of experience in Verification & Validation within Medical Devices domain.
• Experience working on Cardiovascular, Cardiac Monitoring, Heart Pump, ECG/EKG, or similar medical systems is highly preferred.