Lead Test Engineer

The Lead Test Engineer conducts design verification on software products and performs key engineering activities in planning and designing systems. This role focuses on validating software against requirements, ensuring compliance with medical software standards such as IEC 62304, and collaborating closely with design engineering teams to drive continuous improvement in product quality.

Responsibilities

• Perform design verification testing on software to ensure compliance with requirements and applicable medical software standards, including IEC 62304.
• Conduct software regression analysis to evaluate the impact of code changes and confirm that existing functionality remains stable.
• Create and execute predominantly manual test systems, while also developing automated test systems where appropriate.
• Perform detailed interface and requirements analysis to ensure test coverage aligns with functional and non-functional specifications.
• Work with software test tools such as SQL-based tools, Python, Postman, and similar technologies to design, execute, and analyze tests.
• Create clear and comprehensive content for design reviews, including test strategies, test plans, and test results.
• Develop, document, and maintain design verification protocols that define test objectives, methods, and acceptance criteria.
• Execute Design Verification Test (DVT) protocols and prepare thorough test summary reports that clearly communicate results, issues, and risks.
• Collaborate with cross-functional design engineering teams to coordinate and execute verification activities according to project timelines.
• Provide proactive technical feedback and innovative ideas based on test findings to improve product design and overall system performance.
• Participate in and contribute to technical design reviews throughout the design phase, offering insights from a test and verification perspective.
• Work with web and mobile products to ensure that test coverage addresses platform-specific behaviors, interfaces, and performance.
• Support requirements gathering, validation, and traceability activities to ensure all requirements are testable and verified.
• Develop and maintain test procedures and test plans that align with regulatory expectations and internal quality processes.
• Contribute to continuous improvement of testing processes, tools, and documentation to enhance efficiency and effectiveness of verification activities., The Lead Test Engineer works in a structured engineering and product development environment focused on software design and verification. The role involves extensive interaction with web and mobile products and regular use of tools such as SQL-based test utilities, Python, and Postman to design and execute tests. Work typically follows formal design and verification processes aligned with standards like IEC 62304, including design reviews, requirements validation, and documented test protocols. The position requires close collaboration with design engineering teams, participation in technical reviews, and preparation of detailed test documentation and reports. Hours and shift patterns generally align with standard office-based engineering schedules, with work performed in a professional, technology-driven setting.

• Proven experience performing software regression analysis in a structured engineering or product development environment.
• Demonstrated ability to create and execute manual test systems, with exposure to automated testing approaches.
• Strong capability in performing interface and requirements analysis to ensure comprehensive test coverage.
• Hands-on experience with software test tools such as SQL-based tools, Python, Postman, or equivalent technologies.
• Experience creating content for design reviews, including test documentation, test results, and verification evidence.
• Experience performing design verification tests for software-based products, preferably in regulated environments.
• Experience writing detailed design verification protocols that define test methods, acceptance criteria, and documentation requirements.
• Experience testing web and mobile products, including understanding of platform-specific behaviors and constraints.
• Familiarity with IEC 62304 medical software standards or similar software lifecycle standards.
• Strong skills in requirements gathering, validation, and ensuring requirements are testable and traceable.
• Ability to develop and execute test procedures and test plans aligned with project and regulatory needs.
• Bachelor’s degree in Engineering preferred, or equivalent experience in a related technical discipline.

Additional Skills & Qualifications

• Experience coordinating and executing Design Verification Test (DVT) protocols and preparing comprehensive test summary reports.
• Ability to collaborate effectively with design engineering teams and other stakeholders throughout the design and verification phases.
• Demonstrated initiative in providing technical feedback and proposing innovative solutions based on test findings.
• Experience participating in technical design reviews and contributing test-focused insights and risk assessments.
• Strong written and verbal communication skills for documenting test artifacts and presenting results to cross-functional teams.
• Attention to detail and a structured approach to testing, documentation, and compliance with quality processes.
• Experience working in environments that require formal validation and verification activities, such as medical device or other regulated industries., Analysis Skills, Artificial Intelligence (AI), Candidate Screening, Communication Skills, Content Development, Continuous Improvement, Cross-Functional, Design Verification, Detail Oriented, Documentation, Formal Verification, Genetics, Healthcare Software, Hospital, International Electro-Technical Commission (IEC), Mail Services, Maintain Compliance, Medical Equipment, Medical Protocols, Mobile Devices, Presentation/Verbal Skills, Process Improvement, Product Design, Product Development, Project Planning, Protocol Design, Python Programming/Scripting Language, Quality Assurance Methodology, Quality Assurance Software, Quality Management, Regression Testing, Regulations, Regulatory Compliance, Requirements Management, Requirements Validation/Verification, Risk Analysis, SQL (Structured Query Language), Software Design, Software Development, Software Development Lifecycle (SDLC), Software Testing, Software Validation, Team Player, Technical/Engineering Design, Test Automation, Test Design, Test Plan/Schedule, Test Strategy, Testing, Traceability, Validation Documentation, Validation Testing, Verification Engineering, Web Testing, Writing Skills

This is a Permanent position based out of Golden Valley, MN.

Pay and Benefits

The pay range for this position is $55.00 - $80.00/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.