Validation Engineer

Job Summary

We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products.

Roles & Responsibilities

• Plan and execute system-level Verification & Validation (V&V) activities for medical device products.
• Develop, review, and execute validation protocols, test plans, and test reports.
• Perform validation testing, document results, investigate failures, and support issue resolution.
• Ensure validation activities comply with applicable quality standards, regulatory requirements, and internal procedures.
• Collaborate with cross-functional teams including R&D, Quality, Regulatory, Manufacturing, and Systems Engineering.
• Support design verification, risk management, and product validation efforts.
• Maintain accurate documentation in accordance with FDA, ISO 13485, and company quality system requirements.
• Participate in design reviews and provide technical input related to system validation.

Education & Experience

• Bachelor's degree in Engineering or a related technical discipline.
• Minimum 10 years of Validation Engineering experience.
• Strong experience in the Medical Device industry, preferably with infusion pumps or similar electromechanical medical devices.
• Hands-on experience with System-Level Verification & Validation (V&V).
• Prioritized experience executing validation protocols, documenting results, and resolving validation issues.
• Strong understanding of design controls, validation processes, and quality systems.
• Excellent communication and documentation skills.

Preferred

• Experience working with FDA-regulated medical devices.
• Knowledge of ISO 13485, 21 CFR Part 820, IEC 60601, and related medical device standards.
• Previous experience with client or other leading medical device manufacturers.