Embedded Software Test Engineer (Medical Devices)

TekCommands • Burlington, MA

4d

About The Position

We are seeking an experienced Embedded Software Test Engineer to join our Medical Devices team. In this role, you will be responsible for designing, implementing, and executing tests for embedded software systems in medical devices. You will work closely with cross-functional teams to ensure software quality, regulatory compliance, and patient safety through rigorous verification and validation activities.

Requirements

• Bachelor's degree in Computer Science, Electrical Engineering, Biomedical Engineering, or related field
• 6+ years of experience in embedded software testing, preferably in medical devices
• Strong understanding of software development life cycle and V-model
• Knowledge of regulatory requirements for medical device software (FDA, IEC 62304, ISO 13485)
• Familiarity with embedded software debugging tools and techniques

Nice To Haves

• Strong analytical and problem-solving abilities
• Excellent documentation and technical writing skills
• Ability to work effectively in cross-functional teams
• Attention to detail and commitment to quality
• Strong communication skills with both technical and non-technical stakeholders
• Self-motivated with the ability to work independently

Responsibilities

• Create and maintain test documentation in compliance with FDA, IEC 62304, ISO 13485, and other relevant standards
• Participate in risk management activities to identify software-related hazards and mitigations
• Define test coverage requirements based on software requirements and risk analysis
• Design detailed test cases for functional, integration, regression, and system-level testing
• Create test specifications that ensure traceability to software requirements
• Develop automated test scripts for embedded systems using appropriate test frameworks
• Design test environments and fixtures that simulate real-world usage conditions

What This Job Offers

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