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.

Show more Show less