Software Test Engineer

This role focuses on software verification, validation, and testing for a high-reliability medical device product that includes embedded firmware, mobile applications, and cloud-connected applications. The Software Test Engineer applies software quality engineering principles throughout an agile product lifecycle, ensuring that software requirements, design, and implementation meet stringent medical device standards and regulatory expectations., * Support the verification and validation of software for an electromechanical medical device, including firmware, embedded systems, mobile applications, and cloud-connected applications.

• Review software development and testing activities to ensure compliance with documented requirements, established standards, and medical device regulations.
• Apply software quality engineering principles throughout the agile product life cycle to identify defects, design flaws, and process improvement opportunities.
• Review software requirements to confirm they are correct, complete, and unambiguous, and provide feedback to improve clarity and testability.
• Develop, review, and execute test plans and test procedures based on use cases, software requirements, and established test protocols.
• Assist in updating and adding new test cases to existing test protocols to maintain comprehensive test coverage.
• Manage testing tasks for embedded software and firmware, ensuring thorough functional, integration, and system-level testing.
• Review and refine test methods and test plans to verify software design accuracy against documented requirements and applicable standards.
• Collaborate closely with software development and systems engineering teams to improve the quality of deliverables and to introduce quality-related improvements in the software development process.
• Prepare and review test plans, test data, and test scripts, and conduct system and integration testing across firmware, mobile, and cloud components.
• Integrate automated tests into Continuous Integration and Continuous Deployment (CI/CD) pipelines to enable real-time quality monitoring.
• Document test results and engineering data accurately within a Quality Management System (QMS) or related configuration/document management system.
• Contribute to test automation strategy and implementation to increase efficiency and repeatability of testing activities.
• Participate in the testing and validation of cloud-based data storage and processing solutions associated with the medical device.
• Support testing and validation of mobile applications and other software applications related to the medical device ecosystem., This position is based in an office environment, working closely with a growing engineering team on a significant new medical device development effort. The role involves regular collaboration with software, firmware, systems, and quality engineers, as well as frequent interaction with a Quality Management System for documentation and test record management. Work is performed using modern software development and testing toolchains, including CI/CD pipelines, scripting tools such as Python or SQL, and cloud platforms such as AWS or Azure. The environment emphasizes rigorous quality standards, structured documentation, and continuous improvement within an agile development framework.

• At least 5-6 years of relevant experience in software testing, validation, and verification for high-reliability software products.
• Hands-on experience in the medical device field, including work with relevant quality and safety standards such as ISO and IEC standards for medical devices.
• Proven experience testing embedded software and firmware for electromechanical or embedded systems.
• Strong background in software test engineering, including test planning, test procedure development, and execution of verification and validation activities.
• Experience documenting test results and engineering data within a Quality Management System (QMS) or related configuration/document management system.
• Exposure to or experience with cloud technologies used for data storage and processing, such as AWS, Azure, or similar platforms.
• Ability to review and interpret software requirements and translate them into effective test plans, test cases, and test protocols.
• Experience working within an agile software development lifecycle and applying software quality engineering principles.
• Bachelor's degree in engineering or a related technical discipline.

Additional Skills & Qualifications

• Experience with Python scripting, SQL queries, or related scripting languages for test development, automation, or data analysis.
• Experience with software test automation tools and frameworks, including integrating automated tests into CI/CD pipelines.
• Exposure to mobile application testing and other application software testing within a connected device ecosystem.
• Familiarity with FDA 21 CFR Part 820 and its implications for software verification, validation, and documentation in medical devices.
• Experience with validation of cloud-based systems and services, including testing of data storage, processing, and connectivity.
• Knowledge of formal documentation management processes and best practices in regulated environments.
• Strong collaboration skills and the ability to work closely with multidisciplinary engineering teams on large, complex development efforts.
• Motivation to contribute to a growing engineering team working on a major new product development initiative.

This is a Contract to Hire position based out of Germantown, MD.

Pay and Benefits

The pay range for this position is $47.00 - $55.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: - Medical, dental & vision - Critical Illness, Accident, and Hospital - 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available - Life Insurance (Voluntary Life & AD&D for the employee and dependents) - Short and long-term disability - Health Spending Account (HSA) - Transportation benefits - Employee Assistance Program - Time Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.