Verification and Validation Engineer

Enovis; Austin (TX); On-site; USD 110,000 - 150,000; Full time

Job summary

Enovis in Austin is seeking a detail-oriented Verification & Validation Engineer to verify and validate software and system functionality for medical device products within the Enabling Technologies business. This role ensures requirements, designs, and user needs are validated through structured testing in line with medical device standards.

The V&V Engineer II collaborates with Software, Systems, Quality, Regulatory Affairs, Product Development and Program Management to develop test

Qualifications

• Bachelor's degree in a relevant engineering discipline and at least 5 years of software verification and validation experience in regulated environments.
• Experience with SDLC and V&V methodologies in medical devices.
• Ability to create test plans, protocols, cases, and verification reports.
• Strong communication skills and cross-functional teamwork.

Responsibilities

• Develop, execute, and maintain V&V test plans, protocols, and reports for software and system requirements.
• Review requirements and designs to develop validation strategies and test cases.
• Perform hands-on verification and validation testing for new development and enhancements.
• Document results, identify defects, and coordinate with developers for fixes.
• Support regulatory submissions and quality system activities with verification evidence.
• Participate in Agile ceremonies and communicate status to leadership.

Skills

Analytical thinking

Collaboration

Execution excellence

Strong technical writing

Problem solving

Education

Bachelor's degree in Biomedical Engineering, Software Engineering, Computer Engineering, Electrical Engineering, Computer Science, or a related engineering discipline

Job description

Who We Are

ABOUT ENOVIS

Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond.For more information about Enovis, please visit www.enovis.com.

What You'll Do

At Enovis we pay attention to the details. We embrace collaboration with our partners and patients and take pride in the pursuit of scientific excellence - with the goal of transforming medical technology as we know it.
Because that's how we change the lives of patients for the better. And that's how we create better together. Why work at Enovis? See for yourself.

As a key member of the Enabling Tech team, you will play an integral part in helping Enovis drive the medical technology industry forward through transforming patient care and creating better patient outcomes.

Job Title:

Verification & Validation Engineer

Location:

Austin

Job Title/High Level Position Summary:

We are seeking a detail-oriented and collaborative Verification & Validation (V&V) Engineer to support the verification and validation of software and system functionality for medical device products within Enovis' Enabling Technologies business. This role is responsible for ensuring software requirements, system designs, and user needs are thoroughly verified and validated through structured testing activities in compliance with medical device quality and regulatory standards.

The V&V Engineer II will partner closely with Software Engineering, Systems Engineering, Product Development, Quality, Regulatory Affairs, and Program Management teams to develop test strategies, execute verification and validation activities, document results, and support successful product releases. This position requires strong analytical thinking, technical problem-solving skills, and the ability to work effectively within an Agile software development environment.

The ideal candidate is a proactive team player with excellent technical writing and communication skills who is passionate about delivering high-quality, reliable medical device software.

Key Responsibilities

Develop, execute, and maintain verification and validation test plans, protocols, and reports for software and system-level requirements.

Review product requirements, software specifications, and design documentation to develop comprehensive test cases and validation strategies.

Perform hands-on software verification and validation testing for new product development and enhancements to existing products.

Document test results, identify defects, and work closely with development teams to investigate, troubleshoot, and verify software issues.

Review software documentation and participate in quality audits to ensure compliance with applicable medical device standards and company procedures.

Participate in Agile ceremonies, including daily stand-ups, sprint planning, backlog refinement, and retrospectives, providing updates on testing activities.

Track testing progress, maintain defect logs, and communicate project status, risks, and issues to engineering leadership.

Collaborate with cross-functional teams to ensure verification and validation activities support project timelines and product release objectives.

Assist with test planning, test automation initiatives, and continuous improvement of V&V processes and documentation.

Support regulatory submissions and quality system activities by providing verification and validation documentation as required.

Scope / Role Dimensions

Supports verification and validation activities across multiple software and system development projects.

Works collaboratively with Software Engineering, Systems Engineering, Quality, Regulatory Affairs, Product Development, and Program Management teams.

Responsible for executing verification and validation activities throughout the product development lifecycle.

Contributes to product quality, regulatory compliance, and successful product commercialization.

Minimum Qualifications

Bachelor's degree in Biomedical Engineering, Software Engineering, Computer Engineering, Electrical Engineering, Computer Science, or a related engineering discipline.

Minimum of 5 years of experience in software verification and validation, software quality assurance, or medical device development.

Experience working within regulated industries, preferably medical devices.

Knowledge of software development lifecycle (SDLC) and software verification and validation methodologies.

Experience creating test plans, test protocols, test cases, and verification reports.

Strong technical writing, analytical, and organizational skills.

Excellent written and verbal communication skills with the ability to work effectively on cross-functional teams.

Desired Qualifications

Experience working in Agile software development environments.

Familiarity with FDA Quality System Regulation (21 CFR Part 820), IEC 62304, ISO 13485, and other applicable medical device standards.

Understanding of software architecture concepts and software design patterns.

Experience with defect tracking, test management, and requirements management tools.

Basic debugging skills, including reviewing application logs and troubleshooting software issues.

Understanding of musculoskeletal anatomy and orthopedic medical devices is preferred.

Experience supporting software validation for medical device products.

Core Competencies

Quality Focus: Maintains a high standard of accuracy and attention to detail throughout verification and validation activities.

Analytical Thinking: Identifies issues, evaluates risks, and develops practical testing solutions.

Collaboration: Builds strong working relationships across Engineering, Quality, Regulatory, and Product Development teams.

Execution Excellence: Delivers high-quality testing activities while meeting project timelines and regulatory requirements.

Problem Solving: Investigates software defects, supports root cause analysis, and verifies corrective actions.

Communication: Clearly communicates testing progress, risks, and results to technical and non-technical stakeholders.

Travel Requirements

Minimal travel as business needs require.

Who We're Looking For

Detail-oriented and committed to delivering high-quality software products.

Strong technical writer with excellent documentation skills.

Collaborative team player who thrives in a cross-functional engineering environment.

Proactive problem solver who can effectively prioritize multiple assignments.

Adaptable and comfortable working in a fast-paced Agile development environment.

Passionate about improving patient outcomes through innovative medical technology.

Our Enovis Purpose, Values and Behaviors on Vimeo

EQUAL EMPLOYMENT OPPORTUNITY
Enovis provides equal employment opportunities based on merit, experience, and other work-related criteria without regard to race, color, ethnicity, religion, national origin, sex, age, pregnancy, disability, veteran status, or any other status protected by applicable law. We also strive to provide reasonable accommodation to employees' beliefs and practices that do not conflict with Enovis policies and applicable law. We value the unique contributions that every employee brings to their role with Enovis.