Lead Software Verification & Validation Engineer

Our client, an innovative medical device company in Ann Arbor, Michigan, is seeking a Lead Software Test Verification Engineer to support the verification and validation of software used in life-changing medical technologies. This individual will provide technical leadership for a team of Software Test Engineers and will be responsible for planning, coordinating, executing, and documenting software verification and validation activities throughout the product development lifecycle.

The ideal candidate possesses a strong background in medical device software testing, test strategy development, requirements-based testing, and regulatory compliance, along with exceptional communication and leadership skills. This is a highly visible role that will play a critical part in ensuring software quality, product safety, and regulatory compliance during an extensive testing and verification cycle.

• Lead and mentor a team of 3 Software Test Engineers, providing technical guidance, prioritization, and support throughout verification activities.
• Develop, review, and execute comprehensive software verification and validation test plans, protocols, and reports.
• Coordinate testing activities across multiple projects and product releases.
• Ensure requirements traceability from software requirements through verification testing and final documentation.
• Drive execution of functional, integration, system, regression, and performance testing activities.
• Identify testing risks, gaps, and quality concerns and communicate recommendations to project stakeholders.
• Review test results, investigate defects, support root cause analysis, and drive issue resolution efforts.
• Collaborate closely with Software Engineering, Systems Engineering, Quality Assurance, Regulatory Affairs, and Program Management teams.
• Maintain compliance with FDA regulations, ISO 13485, IEC 62304, and company quality management system requirements.
• Monitor testing progress, communicate status updates, and present results to leadership and cross-functional teams.
• Support audit readiness activities and contribute to design verification and validation documentation.
• Drive continuous improvement initiatives related to testing processes, tools, and methodologies.

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• - Bachelor's degree in Computer Engineering, Software Engineering, Computer Science, Biomedical Engineering, or related technical discipline.
• - 8+ years of software testing, software verification, or software validation experience.
• - 2+ years of experience leading or mentoring software test engineers.
• - Proven experience developing and executing software verification and validation test plans.
• - Strong understanding of Software Development Lifecycle (SDLC) and Software Test Lifecycle (STLC).
• - Experience working in a regulated medical device environment.
• - Knowledge of FDA Quality System Regulations and medical device development standards.
• - Experience with requirements-based testing and requirements traceability.
• - Strong defect management, troubleshooting, and root cause analysis skills.
• - Excellent written and verbal communication skills.
• - Proven ability to influence cross-functional teams and communicate effectively with technical and non-technical stakeholders.
• - Strong organizational skills and ability to manage multiple priorities in a fast-paced development environment.
• Preferred Qualifications:
  
  - Experience supporting Class II or Class III medical devices.
• - Knowledge of IEC 62304, ISO 14971, ISO 13485, and FDA design control requirements.
• - Experience with automated testing frameworks and test automation tools.
• - Familiarity with Agile and/or Waterfall development methodologies.
• - Experience with tools such as Jira, Azure Dev Ops, Polarion, DOORS, Test Rail, or similar requirements and test management platforms.
• - Prior experience supporting software verification for embedded systems, connected devices, or safety-critical products.

Intermediate Level

This is a Contract to Hire position based out of Ann Arbor, MI.

The pay range for this position is $75.00 - $90.00/hr.

• 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…