Medical Device Automation & Validation Engineer (Onsite)

BEPC Inc. - Business Excellence Professional Consulting; San Angelo (TX); On-site; USD 55,000 - 62,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

Job summary

BEPC Inc. is actively seeking an Automation and Validation Engineer to join our client’s site in San Angelo, TX. This role focuses on developing, implementing, and maintaining automated systems for medical device production, ensuring validation processes meet FDA, ISO, and industry standards.

The successful candidate will lead IQ/OQ/PQ activities, create robust validation protocols, and document outcomes. Collaboration with cross-functional teams and strong attention to regulatory requirements

Qualifications

• Bachelor's degree in Engineering or related field.
• Minimum 4 years in automation and validation engineering in medical device or regulated industry.
• Knowledge of FDA 21 CFR Part 820 and ISO 13485.

Responsibilities

• Develop, validate, and maintain automated systems for medical device production and testing.
• Lead validation activities (IQ/OQ/PQ) for medical devices per regulatory requirements.
• Create IQ/OQ/PQ validation protocols and validation completion reports.
• Design, implement, and maintain automated test scripts for validation.
• Perform risk assessments and implement corrective actions to improve reliability of automation systems.
• Collaborate with engineering, quality, and regulatory teams to ensure compliance.
• Document validation processes, results, and reports per regulatory standards.

Skills

Automation engineering

Validation testing

IQ/OQ/PQ

Regulatory compliance

FDA 21 CFR Part 820

ISO 13485

Documentation

Cross-functional collaboration

Education

Bachelor's degree in Engineering

Tools

Automation tools

Medical device testing

Job description

BEPC Inc. is actively seeking an Automation and Validation Engineer to join our client’s site in San Angelo, TX. This role focuses on developing, implementing, and maintaining automated systems for medical device production, ensuring validation processes meet FDA, ISO, and industry standards.

The successful candidate will lead IQ/OQ/PQ activities, create robust validation protocols, and document outcomes. Collaboration with cross-functional teams and strong attention to regulatory requirements