Senior Compliance Validation Engineer

Cutera; Raleigh (NC); On-site; USD 120,000 - 160,000; Full time

Job summary

Cutera in Raleigh, NC is seeking an experienced Compliance and Validation Engineer to lead validation strategy across products, embedded software, hardware, and manufacturing processes. You will drive qualification activities (IQ/OQ/PQ) and ensure audit-ready validation documentation.

You will partner with R&D and Manufacturing to support NPI, design transfer, and manufacturing process validation, while maintaining regulatory alignment and high performance standards.

Qualifications

• Bachelor’s degree in Engineering, Quality, or related field.
• 8+ years of validation engineering, quality, or compliance in regulated industries (medical device preferred).
• Strong knowledge of IQ/OQ/PQ with hands-on software/hardware experience.
• Regulatory requirements and ISO 13485 / FDA knowledge.
• Experience with embedded systems, hardware/software integration, and production test methodologies.

Responsibilities

• Lead validation strategies, protocols, and reports for equipment, systems, software, and manufacturing processes.
• Own and drive IQ/OQ/PQ qualifications for production readiness.
• Ensure compliance with FDA/ISO13485 through engineering-driven validation.
• Collaborate across R&D and Manufacturing for NPI, design verification, and transfer to production.
• Develop and maintain validation methods and documentation; support audits.

Skills

Validation principles

IQ/OQ/PQ

Regulatory knowledge

Analytical skills

Communication skills

Education

Bachelor’s degree in Engineering/Quality

Advanced degree preferred

Tools

Enterprise Architect

Markdown

Quarto

PowerShell

JavaScript

Typst

Job description

Cutera in Raleigh, NC is seeking an experienced Compliance and Validation Engineer to lead validation strategy across products, embedded software, hardware, and manufacturing processes. You will drive qualification activities (IQ/OQ/PQ) and ensure audit-ready validation documentation.

You will partner with R&D and Manufacturing to support NPI, design transfer, and manufacturing process validation, while maintaining regulatory alignment and high performance standards.