Sr. Systems Verification and Validation Engineer - Acute Therapies

• Senior Systems V&V Engineer supporting R&D testing of a dialysis medical device. The position is heavily focused on verification and system-level performance testing, rather than manufacturing/production validation.

• Analyze and decompose requirements, develop comprehensive test cases/test plans, execute characterization and formal verification testing, document results, maintain full requirements-to-test traceability, and prepare reports.

• 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.

• 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.

• 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 Codebeamer 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-starter that takes ownership of their work, manages ambiguity, has initiative, and aims to accomplish team and department goals and objectives.

• Primarily electromechanical testing involving pumps, motors, sensors, scales/load cells, pressure sensors, blood-leak/air detection sensors, fluid flow and accuracy testing. Software-only testing experience is less preferred.

• Candidates should be comfortable troubleshooting test failures and performing root-cause analysis to determine whether issues come from the test method, equipment, device, or an actual product failure.

• Experience with statistical sample sizing, test method validation, Gauge R&R, and characterization testing is highly valuable.

• Experience with Minitab, ALM/OpenText, DOORS, Teamcenter, and Jama is helpful. Jama experience could be especially useful because the team is transitioning to it.

• Medical device experience is preferred but not mandatory. Candidates from automotive, defense/military, or other highly regulated industries can be considered if they understand requirements-based testing, documentation, traceability, and structured V&V processes.

• Strong systems/electrical/mechanical engineers without extensive direct testing experience may still be considered if they can take requirements, decompose them, develop tests, and are comfortable doing hands-on lab work.

• Candidates may work with scales, balances, DMMs, oscilloscopes, and other test equipment while physically operating the dialysis machine and running therapies.

• Current work includes characterization, test method validation, and completing test-case development. Q1 Q3 next year will involve extensive test execution followed by reporting.

• Initial screening followed by an approximately 1.5-hour on-site interview with around three team members and a lab/equipment tour. In-person interviews are strongly preferred.

DivIHN is an equal opportunity employer. DivIHN does not and shall not discriminate against any employee or qualified applicant on the basis of race, color, religion (creed), gender, gender expression, age, national origin (ancestry), disability, marital status, sexual orientation, or military status.