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Validation Engineer

Katalyst Healthcares & Life Sciences

Round Lake, IL

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JOB DETAILS
SKILLS
Code of Federal Regulations, Communication Skills, Cross-Functional, Design Verification, Documentation, Electromechanical Systems, Electromechanics, Engineering, FDA (Food and Drug Administration), ISO (International Organization for Standardization), Infusion Pumps, International Electro-Technical Commission (IEC), Maintain Compliance, Manufacturing Requirements, Manufacturing Systems, Medical Equipment, Medical Products, Medical Protocols, Problem Solving Skills, Product Testing, Quality Metrics, Quality System Requirements (QSR), Regulatory Requirements, Research & Development (R&D), Risk Management, System Validation, Systems Engineering, Testing, Validation Documentation, Validation Plan, Validation Testing
LOCATION
Round Lake, IL
POSTED
4 days ago
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).
  • 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.

About the Company

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Katalyst Healthcares & Life Sciences