Sr. Systems Verification and Validation Engineer – Acute Therapies

Sr. Systems Verification and Validation Engineer – Acute Therapies

Work Location: Onsite

Employment Type: Contract

Your Role

As a Senior Systems Verification and Validation Engineer on the Acute Therapies V&V team, you will help demonstrate that products perform as intended for the clinicians and patients who depend on them. You will understand how requirements, design choices, risks, and real-world use shape a thorough and efficient verification and validation (V&V) approach.

Working across disciplines, you will clarify ambiguities surrounding V&V and translate them into practical test strategies. 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 and execution.

What You’ll Be DoingDeliver a Verified and Validated Product

• Define and execute test strategies for system-level, integration, and hardware-level testing.
• Understand the end-to-end verification process to demonstrate that the system meets all requirements.
• Develop and maintain comprehensive V&V documentation, including 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 automated testing strategies that minimize manual testing effort while maintaining regulatory and quality compliance.

Use Data and Statistics to Make Better Decisions

• Characterize product performance using statistical tools such as DOE, ANOVA, and Capability Analysis to identify influential factors, meaningful operating ranges, sources of variation, and worst-case conditions.
• Use characterization 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 trade-offs clearly to technical and nontechnical partners.

Drive Product Quality Through Insight and Execution

• 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 to identify root causes, contributing factors, and implications for product quality.
• Drive defects from identification through investigation, resolution, and verification, working across disciplines to implement 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.

What You’ll BringMinimum Requirements

• Bachelor’s degree or equivalent degree earned outside the United States in an engineering field, with a minimum of 4 years of relevant experience; or
• Advanced degree in an engineering field with a minimum of 2 years of relevant experience.

Preferred Qualifications

• 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 skills, and sound judgment when requirements, interfaces, or test results are ambiguous, with the ability to work across disciplines to establish a documented path forward.
• Working knowledge of applied statistics and experimental design, including selecting appropriate analyses, justifying sampling approaches, and explaining what test data does and does not establish.
• Experience with complex electromechanical, software-controlled systems, particularly medical devices developed under a rigorous quality system.
• Product development experience in an Agile or iterative environment utilizing continuous integration.
• Experience with requirements and test-management systems such as DOORS, OpenText ALM, Jama Connect, Polarion, or Codebeamer for creating, reviewing, and tracing product development content.
• Ability to analyze data using Minitab, R, Python, MATLAB, or similar tools and communicate findings through clear technical reports or dashboards.
• Ability to develop dashboards and product performance reports using Monday.com, Power BI, Smartsheet, or similar systems.

Ideal Candidate Profile

An engaged self-starter who takes ownership of their work, manages ambiguity, demonstrates initiative, and consistently works toward team and department goals and objectives.