Embedded Software Test Engineer (Medical Devices)
Burlington, CO - USA
Job Summary
Job Description:
We are seeking an experienced Embedded Software Test Engineer to join our Medical Devices 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.
We are seeking an experienced Embedded Software Test Engineer to join our Medical Devices 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.
Key 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
Mandatory skills
Bachelors 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
Optional skills
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
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