REVIAN · 5 hours ago
Senior Validation Engineer
Morrisville, NC
Full-time
Onsite
Senior Level
5+ years expREVIAN Inc is a medical technology innovator dedicated to rejuvenating hair and skin with light. They are seeking a Senior Validation Engineer to validate computer systems software and ensure compliance with US FDA and ISO 13485 requirements.
Health CareManufacturingMedical
No H1B
Hiring Manager
Darlene Dendy
Responsibilities
Develop and execute computer software systems validations for off the shelf and custom designed software and spreadsheets in accordance with FDA guidance documents, specifically, •Computer Software Assurance for Production and Quality Management System Software• (Feb 3, 2026) and •General Principles of Software Validation,• as well as ISO 13485 computer system validation requirements
Develop and execute equipment and process validations for internal company equipment/processes including custom designed equipment allocated and transferred to contract manufacturers
Develop a master validation file for equipment/software including but not limited to validation plans, requirements, risk analyses, test protocols, and test reports
Assist Quality in Change Management
Perform duties and other analyses as requested by members of management
Adhere to and ensure compliance with Revian’s quality system
Qualification
Required
BSc, MSc, or PhD in an engineering or physical science field
5+ years of experience in the medical device industry and within a Quality System compliant with 21 CFR 820 or ISO 13485
5+ years of experience in Computer System Validation for the Medical Device industry
Ability to work with teams on site to develop and document requirements. Excellent written skills a must have
Prioritize and manage multiple projects in a fast-paced environment with minimal supervision while maintaining strong attention to detail
Self-starting and self-motivating team player with the ability to work autonomously
Willingness to quickly adapt to changing priorities and manage multiple tasks
Strong interpersonal skills, effective written and verbal communication, problem solving, and decision-making skills
Preferred
Experience with measurement methods and measurement equipment
Detailed knowledge of Microsoft Project, Smartsheet, or other project management software
Company
REVIAN
Revian is the manufacturer and supplier of medical-grade LED technology.
11-50 employees
Funding
Current Stage
Early StageTotal Funding
$13MKey Investors
Flashpoint
2025-11-20Series Unknown· $13M
2025-11-20Debt Financing
Leadership Team
Amy Miller Keish
Vice President of Healthcare Sales
Recent News
2025-11-25
Company data provided by crunchbase