Embedded Test Engineer (Medical Devices)

TL;DR

Embedded Test Engineer (Medical Devices): Performing manual software testing for an Optical Coherence Tomography (OCT) imaging platform with an accent on Windows-based application verification and embedded system interfaces. Focus on ensuring compliance with medical device safety standards and maintaining rigorous requirements traceability within a regulated environment.

Location: 100% onsite in Westford, MA

Salary: $68,911 – $161,544

Company

hirify.global is a global leader in engineering and technology services, providing R&D and digital transformation solutions across diverse industries.

What you will do

• Design, document, and execute manual test protocols including functional, regression, and usability tests.
• Verify software behaviors against requirements, specifically focusing on embedded system interaction and image acquisition workflows.
• Identify, record, and track defects through resolution using standard management tools.
• Maintain requirements traceability between specifications, test cases, and results.
• Author and maintain test documentation in compliance with quality management systems and regulatory standards.
• Collaborate with software, systems, and quality teams to support release readiness.

Requirements

• Bachelor’s degree in Computer Science, Software Engineering, Biomedical Engineering, or related field.
• Minimum 3 years of experience in software testing and embedded devices verification.
• Minimum 2 years of hands-on experience in manual test protocols for class III medical devices.
• Strong knowledge of verification standards including ISO 13485, ISO 14971, and FDA 21 CFR Part 820.
• Ability to work 100% onsite in Westford, MA.

Culture & Benefits

• Comprehensive benefits package including medical, dental, and vision coverage.
• Retirement savings plans such as 401(k).
• Paid time off including vacation, company holidays, and sick leave.
• Life and disability insurance.
• Employee assistance programs.