Senior Process Engineer | Medical Device (IQ/OQ/PQ) - Bukit Batok

Job description

Process Engineer responsible for ensuring the quality and integrity of data, systems, processes, and products meet regulatory and quality standards. This role involves developing and executing validation protocols, analysing data, and documenting results to ensure the safety and effectiveness of medical devices.

Job Descriptions:

• Develop and implement a methodology for the implementation of new and improved processes, and validation plans for medical devices including software, hardware and firmware.
• Manage and develop validation protocols (IQ/OQ, PQ), execute validation tests and document results accurately.
• Analyze validation results to determine if the system or process meets validation criteria. Identify defects, deviations or areas for improvement.
• Ensures accurate and complete documentation of validation results, including reports and certification.
• Identify and mitigate risks associated with medical device validation, including patient safety and regulatory compliance.
• Ensures validation activities comply with domestic and international Laws and regulatory standards (e.g., FDA, ISO 13485, WHO).
• Support the internal and external audit by providing validation documentation and explanations. Ensure readiness for regulatory inspections.
• Work closely with design and manufacturing teams to implement improvements and correct defects.
• Provide technical support and training to team members on the validation process.
• Stay updated with emerging trends, technologies, and medical device production regulations.
• Collaborates with cross-functional teams, including Engineering, Manufacturing, Quality Assurance and Others.
• The main technical window for new products and existing mass-production parts.
• Evaluate processes for CIP and develop implementation methodology while improving cost-effectiveness.
• Trial new tooling and equipment and make modifications as needed to meet quality and production goals.
• Liaison with customer engineering teams, incorporate customer engineering concepts, and ideas into feasible designs to fit facility/company manufacturing process.
• Work closely with the internal engineering team and outside vendors in tooling, equipment, component and material development.
• Work closely with customers on product, project or system development issues.

• Degree in Biomedical/Mechanical Engineering/relevant field.
• More than 5 years of experience in process validation, preferably in the medical device industry.
• Strong understanding of FDA, GMP and ISO 13485 standards; proficiency in statistical analysis and risk assessment methodologies; excellent knowledge of Minitab, MES, SAP and excellent technical writing skills.

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