Sr. Systems Verification & Validation

Job Title: Sr. Systems Verification & Validation

Location: Onsite Plymouth MN

Contract: 12 months

USC

Job Description

Job Summary:
Client is seeking a Senior Systems Verification & Validation Engineer to support the Acute Therapies team in verifying and validating medical devices. The candidate will develop and execute system-level, integration, and hardware testing strategies to ensure products meet requirements, design specifications, safety, quality, and regulatory standards.

Key Responsibilities:

• Develop and execute system, integration, and hardware verification and validation test plans.
• Prepare verification protocols, reports, traceability matrices, risk assessments, and test method validation documentation.
• Apply statistical methods such as DOE, ANOVA, and capability analysis to evaluate product performance and test results.
• Determine appropriate sample sizes, identify worst-case conditions, and analyze product variability.
• Investigate test failures, perform root-cause analysis, manage defects, and verify corrective actions.
• Collaborate with cross-functional engineering, quality, and product development teams.
• Improve testing efficiency through automation, simulation, inspection, and alternative verification methods.
• Maintain compliance with medical device quality systems and regulatory requirements.

Must-Have Qualifications:

• Bachelor's degree in Engineering with 4+ years of relevant experience, or an advanced Engineering degree with 2+ years of relevant experience.
• Hands-on experience in systems verification and validation, test planning, execution, and documentation.
• Strong understanding of requirements traceability, risk-based testing, and structured problem-solving.
• Knowledge of applied statistics, DOE, ANOVA, sample-size justification, and data analysis.
• Experience with complex systems; medical device or electro-mechanical product experience is highly preferred.

Preferred Skills:

• Requirements/test management tools: DOORS, Jama Connect, Polarion, OpenText ALM, or Codebeamer.
• Data analysis tools: Minitab, Python, R, or MATLAB.
• Dashboard/reporting tools: Power BI, Monday.com, or Smartsheet.
• Agile product development and continuous integration experience.
• Strong communication, analytical, and cross-functional collaboration skills.

Ideal Candidate: A hands-on V&V Engineer with medical device or complex product development experience, strong statistical analysis skills, and expertise in test strategy, requirements traceability, and root-cause investigation.

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Must-Have Skills Senior Systems Verification & Validation Engineer | Vantive

1. 1. Education: Bachelor's degree in Engineering + 4 years of relevant experience, or advanced Engineering degree + 2 years of relevant experience.
   2. Systems V&V: Hands-on experience in verification and validation, including test planning, test development, execution, and documentation.
   3. Test Documentation: Experience creating test plans, protocols, reports, and requirements traceability matrices.
   4. Statistical Analysis: Knowledge of DOE, ANOVA, capability analysis, sample-size justification, and interpretation of test data.
   5. Root Cause Analysis: Experience investigating test failures, identifying root causes, managing defects, and verifying corrective actions.
   6. Systems Engineering: Ability to connect product requirements, design specifications, risks, and test strategies.
   7. Medical Devices / Complex Products: Experience with complex electro-mechanical or software-controlled systems; medical device experience is highly preferred.
   8. Onsite Availability: Must be able to work onsite.

Preferred Tools: DOORS, Jama Connect, Polarion, OpenText ALM, Codebeamer, Minitab, Python, R, MATLAB, or Power BI.

Navnish kumar

Sr. IT Technical Recruiter

Stellent IT Phone:

Email: navnish
Gtalk: navnishom