Overview In this role you will lead system-level Verification and Validation for medical device products, shaping validation plans, protocols, and reports to ensure quality and regulatory compliance. You will work closely with R&D, Quality, Regulatory, Manufacturing, and Systems Engineering to support design verification, risk management, and product validation. Your efforts will ensure adherence to FDA, ISO 13485, and internal quality systems while resolving validation issues and documenting results. This is an opportunity to impact patient safety and device reliability within a collaborative, regulated environment.
Responsibilities- Plan and execute system-level 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 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 per FDA, ISO 13485, and company quality system requirements
- Participate in design reviews and provide input related to system validation
Key requirements- Bachelor in Engineering
- Minimum 10 years of Validation Engineering experience
- Strong experience in Medical Device industry, preferably infusion pumps or similar electromechanical 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
- Communication
- Documentation
- Cross-functional collaboration
- System-Level Verification & Validation (V&V)
- Validation protocols
- Regulatory knowledge (FDA, ISO 13485, 21 CFR Part 820, IEC 60601)
