What are the responsibilities and job description for the Validation Engineer position at Katalyst Healthcares and Lifesciences?
Job Summary:
- 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.
- 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.
- 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.