Verification and Validation Engineer
enovis · Austin
Job description
About the role
Enovis is seeking a detail‑oriented Verification & Validation Engineer to ensure software and system functionality for medical device products meets rigorous quality and regulatory standards. The role collaborates across engineering, quality, regulatory, and program teams within an Agile environment.
Key responsibilities
- Develop, execute, and maintain verification and validation test plans, protocols, and reports for software and system‑level requirements.
- Perform hands‑on testing, document results, track defects, and work with development teams to resolve issues.
- Participate in Agile ceremonies, provide status updates, and ensure V&V activities align with project timelines.
- Support regulatory submissions and quality system activities by supplying required documentation.
Required profile
- Bachelor’s degree in Biomedical Engineering, Software Engineering, Computer Science or related field.
- Minimum 5 years of experience in software verification and validation, preferably in medical devices.
- Experience working in regulated environments and familiarity with FDA QSR, IEC 62304, ISO 13485.
- Strong analytical, technical writing, and communication skills.
Required skills
- Software verification and validation methodologies.
- Test planning, test case creation, and defect tracking.
- Agile software development processes.
- Knowledge of FDA Quality System Regulation (21 CFR 820), IEC 62304, ISO 13485.
- Robotics experience and basic debugging skills.
What we offer
- Medical, dental, and vision insurance.
- 401(k) plan and income protection.
- Paid vacation, sick leave, and holidays.
- Spending and savings accounts.
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Published 1 day ago
Expires 1 month from now
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enovis
Austin
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