What are the responsibilities and job description for the Embedded Test Engineer - Medical Devices position at Capgemini Engineering?
Location
100% onsite- Westford, MA
About the job you’re considering
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.
Your role
- 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.
Your skills and experience
- 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.