Sr. Systems Verification and Validation Engineer - Acute Therapies

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Title: Sr. Systems Verification and Validation Engineer Acute Therapies
Location: Plymouth, MN
Duration: 12 Months With possible Extension and with conversion to Full-Time

Relocation : Candidates willing to relocate at their own expense may be considered, but they should ideally be available for an in-person final interview.

Hands-on Role

• Requires significant lab work and is on-site 5 days/week. Initially about 75% hands-on testing, increasing to approximately 80 90% during formal testing next year. Later phases will shift more toward analysis, reports, and documentation.

Only W2 candidates are eligible for this position. Third-party or C2C candidates will not be considered.

Job Description:

Your Role
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.

Role Focus

• 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.

Key Responsibilities:

• 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.

What You'll Be Doing
Deliver 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 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.

Use Data and Statistics to Make Better Decisions

• 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.

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. 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.

What You'll Bring



Minimum 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.

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, 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.

Testing:

• 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.

Technical Skills:

• 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.

Statistical/Test Method Skills:

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

Preferred Tools:

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

Industry Background:

• 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.

Candidate Flexibility:

• 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.

Lab Equipment:

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

Project Timeline:

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

Interview Process:

• 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.

About us:

DivIHN , the 'IT Asset Performance Services' organization, provides Professional Consulting, Custom Projects, and Professional Resource Augmentation services to clients in the Mid-West and beyond. The strategic characteristics of the organization are Standardization, Specialization, and Collaboration.

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.