What are the responsibilities and job description for the Automation and Validation Engineer – Medical Device Compliance Specialist position at BEPC Inc. - Business Excellence Professional Consulting?
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 development 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.
- Strong knowledge and experience in generating equipment and fixture matrices for MVP, with qualification requirements defined by the medical device company.
- Create detailed and specific IQ/OQ validation protocols for medical device manufacturing and laboratory settings in accordance with client requirements and standards.
- Upon successful completion of IQ/OQ validations, author validation completion reports.
- Execute detailed and technical PQ validations as per client requirements and standards.
- Successful completion of PQ validations, and 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 automated systems.
- Collaborate with engineering, quality, and regulatory teams to ensure that all 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 automation and validation within medical device development.
Education & Experience Requirements
- Bachelor's degree in Engineering, Electrical or, or related field (Master’s preferred).
- Minimum of 4 years of experience in automation and validation engineering, specifically in the medical device or regulated industry.
- Strong knowledge of regulatory requirements, including FDA 21 CFR Part 820, ISO 13485.
- Experience with automation tools and systems.
- Familiarity with risk management processes (e.g., FMEA) and statistical analysis.
- Solid understanding of test methodologies and validation protocols (IQ, OQ, PQ).
- Excellent problem-solving, troubleshooting, and analytical skills.
- Strong attention to detail and excellent documentation practices.
- Effective communication and interpersonal skills to work collaboratively with cross-functional teams.
