Senior Systems V&V Engineer - Medical Devices, Data-Driven

VIVA USA Inc; Plymouth (MN); On-site; USD 110,000 - 150,000; Full time

Job summary

VIVA USA Inc. seeks a Senior Systems Verification and Validation Engineer in Plymouth, MN. You will design and execute strategies across system, integration, and hardware tests to show the product meets requirements and quality standards.

You will build and maintain verification plans and risk-based reports, analyze data with DOE/ANOVA, and drive improvements across the V&V lifecycle in a regulated medical devices environment.

Qualifications

• Bachelor’s degree in engineering; 4+ years of relevant experience, or advanced degree with 2+ years.
• Hands-on verification/validation testing experience for complex medical devices.
• Experience with DOORS, ALM/Jama/Polarion/Codebeamer for traceability.

Responsibilities

• Define and execute system-level, integration, and hardware verification strategies.
• Develop verification plans, protocols, reports with traceability and risk assessments.
• Provide updates and communicate findings to cross-functional teams.
• Drive continuous improvement of the verification and validation process.
• Establish alternative verification approaches to minimize manual testing while maintaining compliance.
• Characterize product performance using DOE, ANOVA, and capability analysis.
• Document defensible sample-size and analysis rationales based on risk and data.
• Turn data into actionable recommendations and communicate uncertainties clearly.

Skills

Test planning

Verification testing

Validation testing

Statistical methods

DOE/ANOVA

Data analysis

Agile/CI

Regulatory mindset

Education

Bachelor’s degree in engineering

Tools

DOORS

OpenText ALM

Jama Connect

Polarion

Codebeamer

Minitab

R

Python

MATLAB

Job description

VIVA USA Inc. seeks a Senior Systems Verification and Validation Engineer in Plymouth, MN. You will design and execute strategies across system, integration, and hardware tests to show the product meets requirements and quality standards.

You will build and maintain verification plans and risk-based reports, analyze data with DOE/ANOVA, and drive improvements across the V&V lifecycle in a regulated medical devices environment.