Verification and Validation Engineer

Enovis•Austin, TX

2d•Onsite

About The Position

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.

Requirements

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.

Nice To Haves

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.

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.