Validation Engineer

Creative Solutions Services, LLC; Boston (MA); On-site; USD 140,000 - 210,000; Full time

Job summary

Creative Solutions Services, LLC is seeking an experienced Validation Engineer to support system-level Verification & Validation (V&V) activities for medical device products. You will plan and execute V&V, develop validation protocols, and ensure compliance with FDA, ISO 13485, and internal quality system requirements.

Ideal candidates have 10+ years in Validation Engineering within the Medical Device industry, hands-on V&V, and knowledge of FDA/ISO 13485 standards.

Qualifications

• Bachelor's degree in Engineering or a related technical discipline.
• 10+ years of Validation Engineering experience.
• Strong experience in Medical Device industry, preferably with 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.
• Experience working with FDA-regulated medical devices is preferred.

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 Verification & Validation

Validation testing

Education

Bachelor's degree in Engineering or related technical discipline

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.