Bachelor's degree in Engineering or related technical discipline
10+ years of Validation Engineering experience
Strong background in the Medical Device industry, especially with infusion pumps
Hands-on experience with System-Level Verification & Validation (V&V)
Experience in executing validation protocols and resolving issues
Solid understanding of design controls and quality systems
Excellent communication and documentation skills
Responsibilities
Plan and execute system-level V&V activities for medical devices
Develop and review validation protocols and test reports
Perform validation testing and support issue resolution
Ensure compliance with quality standards and regulatory requirements
Collaborate with cross-functional teams including R&D and Quality
Support design verification and product validation efforts
Maintain accurate documentation per FDA and ISO standards
Participate in design reviews and provide technical input
Benefits
Collaborative work environment
Opportunity to work on FDA-regulated medical devices
Exposure to cross-functional teams
Support for professional development
Opportunity to impact healthcare outcomes through technology
Full Job Description
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.
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).
