Lead Software Verification & Validation Engineer

Description

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. Key Responsibilities 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.

Skills

Validation, software testing, validation verification, medical, medical device

Top Skills Details

Validation,software testing,validation verification,medical,medical device

Additional Skills & Qualifications

Must Haves: - 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 DevOps, Polarion, DOORS, TestRail, or similar requirements and test management platforms. - Prior experience supporting software verification for embedded systems, connected devices, or safety-critical products.

Experience Level

Intermediate Level

Job Type & Location

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

Pay and Benefits

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

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

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

This is a fully onsite position in Ann Arbor,MI.

Application Deadline

This position is anticipated to close on Oct 15, 2026.

About Actalent

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 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.