As a Manufacturing Technician specializing in electromechanical medical devices, you will play a vital role in ensuring the optimal performance of our medical devices, test stations, and manufacturing cells.
Maintain and Troubleshoot Manufacturing Systems: Perform and manage routine maintenance, calibration, and repairs on manufacturing equipment and systems; conduct root cause analysis and implement corrective actions to minimize downtime and ensure compliance with quality standards.
Drive Continuous Improvement: Collaborate with engineering, quality, and production teams to identify and resolve technical challenges using standard CI tools such as Fishbone diagrams, 5 Whys, and structured problem-solving methodologies.
Support Process Validation Activities: Assist in the execution of product and process validation protocols, equipment re-validations, and updates to related procedures and Bills of Materials (BOMs).
Process Monitoring and Reporting: Monitor line performance by tracking yield, defects, scrap, and process capabilities; document and report findings to management to support operational decisions.
Production Equipment Setup and Management: Configure and maintain electromechanical production and test equipment according to specifications; manage equipment calibration schedules and documentation in alignment with regulatory and company procedures.
2-year technical degree or equivalent with 5+ years of experience in manufacturing operations environment preferably in the medical device industry.
Familiarity with the requirements of ISO 13485 and FDA 21 CFR 820 pertaining to quality management systems, including document control, record keeping, and change management processes.
Demonstrated experience with the validation, documentation, and manufacture of medical devices is a plus.
Ability to successfully perform the minimum Physical, Cognitive and Environmental job requirements with or without accommodation.
Strong interpersonal communication and teamwork skills and proven problem-solving skills.