Senior Systems Verification and Validation Engineer

Stefanini Group • Plymouth, MN

4d • Onsite

About The Position

As a Senior Systems Verification and Validation Engineer on client's Acute Therapies V&V team, you will help demonstrate that our products perform as intended for the clinicians and patients who depend on them. You understand how requirements, design choices, risks, and real-world use should shape a thorough and efficient V&V approach. Working across disciplines, you will clarify ambiguities surrounding V&V and turn them into practical test strategies which others can follow. You will use experimental design and statistical reasoning to select appropriate tests, interpret performance results, and support engineering decisions. You will also develop and improve test methods, validate those methods, support test tool qualification, and improve the effectiveness of test planning & execution.

Requirements

• Bachelor's degree (or equivalent degree earned outside of the United States) in an engineering field and minimum of 4 years of relevant experience, or advanced degree in an engineering field with a minimum of 2 years relevant experience.

Nice To Haves

• Hands-on experience planning, developing, executing, and documenting verification or validation tests for complex products, with the ability to connect requirements and risks to objective evidence.
• Demonstrated systems thinking, structured problem solving, and sound judgment when requirements, interfaces, or test results are ambiguous; ability to work across disciplines to reach a documented path forward.
• Working knowledge of applied statistics and experimental design, including the ability to choose an appropriate analysis, justify a sampling approach, and explain what test data does and does not establish.
• Experience with complex, electro-mechanical, software-controlled systems, particularly medical devices developed under the rigor of a quality system.
• Product development experience working in an Agile/iterative environment utilizing continuous integration.
• Experience with requirements and test-management systems such as DOORS, OpenText ALM, Jama Connect, Polarion, or Code beamer used to create, review, and trace all product development content.
• Ability to analyze data with Minitab, R, Python, MATLAB, or similar tools and communicate findings in clear technical reports or dashboards.
• Ability to develop dashboards and product performance reports leveraging Monday.com, PowerBI, Smartsheet, or similar systems.
• Engaged self-starters that takes ownership of their work, manages ambiguity, has initiative, and aims to accomplish team and department goals and objectives.

Responsibilities

• Define and execute test strategies for system-level, integration, and hardware-level testing.
• Understand the end-to-end verification process which ultimately demonstrates the system meets all requirements.
• Develop and maintain comprehensive V&V documentation, including but not limited to verification plans, verification protocols and reports, test method validations, traceability matrices, and risk assessments.
• Provide regular updates and communicate progress, findings, and recommendations to cross-functional teams, stakeholders, and management.
• Drive continuous improvement initiatives to enhance the efficiency and effectiveness of the verification and validation process.
• Establish alternative verification approaches, including inspection, verification via trace, design review, analysis, simulation, and or automated testing strategies which minimize manual testing effort while maintaining regulatory and quality compliance.
• Characterize product performance (using statistical tools such as DOE, ANOVE, and Capability Analysis) to identify influential factors, meaningful operating ranges, sources of variation, and worst-case conditions.
• Use results to focus formal testing where it adds the most value.
• Define and document defensible sample-size and analysis rationales based on risk, variability, available characterization or historical data, and the type of evidence needed.
• Turn data into actionable recommendations by distinguishing signal from noise, assessing performance margins, and communicating uncertainty and tradeoffs clearly to technical and nontechnical partners.
• Develop a deep understanding of product function, requirements, and design intent to assess the impact of changes and issues, shape test strategy, and build effective V&V plans.
• Investigate unexpected results using structured problem-solving methods.
• Look beyond the immediate failure to identify root causes, contributing factors, and implications for product quality.
• Drive defects from identification through investigation, resolution, and verification, working across disciplines to turn findings into effective solutions.
• Communicate findings and recommendations clearly, using evidence to help the team prioritize issues, and make informed decisions.
• Anticipate obstacles, unblock work, and find creative ways to meet challenging schedules while preserving the rigor and quality of V&V evidence.

Benefits

• Listed salary ranges may vary based on experience, qualifications, and local market. Also, some positions may include bonuses or other incentives.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior