We are seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products. The role involves planning and executing V&V activities, developing and executing validation protocols, supporting design verification, and ensuring compliance with
FDA, ISO
13485, and internal quality system requirements. Experience with infusion pump systems or similar electromechanical medical devices is preferred.
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). Proven 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.
Preferred:
Knowledge of
ISO 13485, 21 CFR
Part 820, IEC 60601, and related medical device standards.
Preferred:
Previous experience with client or other leading medical device manufacturers.
