Job Description: Automation and Validation Engineer
We are seeking a highly skilled and motivated Automation and Validation Engineer to join our team in the medical device industry. Responsible for developing, implementing, and maintaining automated systems and ensuring validation processes comply with industry standards and regulatory requirements. Collaborate with cross-functional teams to drive the manufacturing and testing of medical devices to meet safety, quality, and performance criteria.
Position Duties & Responsibilities:
· Develop, validate, and maintain automated systems for medical device production and testing.
· Lead and execute validation activities including Software, Hardware, and Process Validation for medical devices in compliance with FDA, ISO, and other regulatory requirements.
· Create detailed and specific IQ/OQ/PQ validation protocols for medical device manufacturing equipment and laboratories in accordance with client requirements and industry standards.
· Upon successful completion of IQ/OQ/PQ validations, author validation completion reports.
· Design, implement, and maintain automated test scripts, ensuring all validation protocols are met.
· Perform risk assessments and provide corrective actions to improve the reliability of equipment and automated systems.
· Collaborate with production, engineering, quality, and regulatory teams to ensure that automation and validation activities meet industry standards.
· Document validation processes, results, and reports in compliance with applicable regulatory standards.
· Support new product development and process improvement efforts through automation and validation strategies.
· Troubleshoot and resolve issues related to automated systems and ensure the reliability of validation equipment.
· Maintain up-to-date knowledge of industry regulations and best practices in equipment and validation within the medical device industry.
Education & Experience Requirements
· Bachelor's degree in Engineering, Electrical, Mechatronics, or related field (Master’s preferred).
· Minimum of 4 years of experience in equipment automation and validation engineering, specifically in the medical device or regulated industry, including FDA 21 CFR Part 820, ISO 13485.
· Excellent problem-solving, troubleshooting, and analytical skills.
· Effective communication and interpersonal skills to work collaboratively with cross-functional teams.
· Strong knowledge and experience in generating equipment and tooling matrices for MVP, with qualification requirements defined for the medical device company.
· Familiarity with risk management processes (e.g., FMEA) and statistical analysis.
· Solid understanding of test methodologies and validation protocols (IQ, OQ, PQ).
· Strong attention to detail and excellent documentation practices.
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