Senior/Lead Test Engineer - Medical Devices

Job Title: Senior/Lead Test Engineer - (Medical Devices/Cardiac Devices)

Location:  Boston, MA, USA

Website: www.agiliad.com

Visa Status: Local candidates preferred. Must be authorized to work in the US without company sponsorship

About Agiliad

Agiliad is a global Product Engineering, R&D and Digital Transformation Services company collaborating with leading global technology and product companies to innovate and help them realize their product development goals. We offer a unique combination of domain focus and a deep understanding of product platforms and diverse technologies - ‘A chip-to-cloud collaboration’.

Job Summary:

We are looking for a highly skilled Senior 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. 
• 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. 
• Hands-on experience with LabVIEW and data acquisition systems. 
• 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. 

Qualifications:

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