Validation Engineer

Creative Solutions Services, LLC; Round Lake (IL); On-site; USD 120,000 - 180,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an experienced Validation Engineer to lead system-level Verification & Validation activities for medical device products. You will plan, execute and document validation protocols, support design verification, and ensure compliance with FDA, ISO 13485, and internal quality systems.

The ideal candidate has a Bachelor's degree in engineering, 10+ years in validation engineering within the medical device industry, and hands-on experience with V&V,

Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• Minimum 10 years of Validation Engineering experience.
• Extensive experience in the Medical Device industry, preferably with infusion pumps or similar electromechanical devices.
• Hands-on System-Level Verification & Validation (V&V) experience.
• Proven ability to execute validation protocols, document results, and resolve validation issues.
• Strong knowledge of design controls, validation processes, and quality systems.
• Excellent communication and documentation skills, with FDA-regulated device experience preferred.
• Knowledge of ISO 13485, 21 CFR Part 820, IEC 60601 and related standards.

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.

Skills

System-level Validation & Verification

Validation protocols

Test plans

Test reports

Documentation

Design controls

Regulatory requirements

FDA compliance

ISO 13485

Education

Bachelor's degree in Engineering

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).
• 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.