Embedded Test Engineer- Medical Devices

Capgemini • Burlington, MA

1d • $68,911 - $161,544 • Onsite

About The Position

At Capgemini Engineering, the world leader in engineering services, we bring together a global team of engineers, scientists, and architects to help the world’s most innovative companies unleash their potential. From autonomous cars to life-saving robots, our digital and software technology experts think outside the box as they provide unique R&D and engineering services across all industries. Join us for a career full of opportunities. Where you can make a difference. Where no two days are same. We are seeking a detail-oriented Embedded Test Engineer to perform manual software testing of our Optical Coherence Tomography (OCT) imaging platform. The role focuses on verifying the Windows-based application and its interfaces to the embedded system, ensuring the software meets functional, usability, and safety requirements within a regulated medical device environment. The engineer will design and execute manual test cases, document results, and collaborate closely with software, systems, and quality teams throughout the product development lifecycle.

Requirements

• Bachelor’s degree in computer science, Software Engineering, Biomedical Engineering, or a related technical discipline.
• Minimum of 3 years’ experience in software testing and experience in embedded devices verification.
• Minimum 2 years of hands-on experience in designing and executing manual test protocols for class III medical devices quality.
• Strong experience with verification standards (e.g., ISO 13485, ISO 14971 and FDA 21 CFR Part 820), including software verification and validation practices.

Responsibilities

• Design, document, and execute manual test cases and protocols (functional, regression, exploratory, and usability) for the Windows-based application.
• Verify software behaviors against requirements, including interaction with the embedded system and OCT image acquisition and display workflows.
• Identify, record, and track defects through resolution using a defect management tool, providing clear and reproducible reports.
• Maintain requirements traceability between specifications, test cases, and results to support design verification and validation.
• Author and maintain test documentation in compliance with the company quality management system and applicable regulatory standards.
• Collaborate with software developers, systems engineers, and QA to support release readiness and continuous improvement of test processes.

Benefits

• Paid time off based on employee grade (A-F), defined by policy: Vacation: 12-25 days, depending on grade, Company paid holidays, Personal Days, Sick Leave
• Medical, dental, and vision coverage (or provincial healthcare coordination in Canada)
• Retirement savings plans (e.g., 401(k) in the U.S., RRSP in Canada)
• Life and disability insurance
• Employee assistance programs
• Other benefits as provided by local policy and eligibility

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level