Engineering Technician

• Follow engineering direction to perform hands-on evaluation, repair, rework, and modification of electromechanical assemblies and components in accordance with approved procedures and quality standards.
• Execute engineering test plans created by the manufacturing engineering team, and collect data to support product verification, process validation, root cause investigations, and process improvements.
• Work closely with production lines to gain a thorough understanding of manufacturing processes, materials, and equipment, enabling effective troubleshooting and continuous improvement of production issues.
• Assist the manufacturing engineering team with product and process development activities, including engineering builds, new product introductions, and manufacturing transfers.
• Write and maintain standard operating procedures (SOPs) and assist with training Production Operators and Technicians on SOPs.
• Support process validation activities (IQ/OQ/PQ), data collection, and continuous improvement initiatives to enhance quality, efficiency, and manufacturability.
• Perform testing, troubleshooting, and root cause investigations of products, equipment, and manufacturing processes to resolve technical issues.
• Create, maintain, and revise controlled manufacturing documentation, including work instructions, test methods, engineering change records, and assembly procedures.
• Ensure compliance with ISO 13485, MDSAP, FDA regulations, and internal quality system requirements while supporting audits, CAPA activities, change control, and risk management processes.

• Either a High school diploma or equivalent AND 4+ years of experience working as a production or engineering technician in a manufacturing environment, OR Associate's degree or greater in a STEM discipline AND 1+ years of experience working as a production or engineering technician in a manufacturing environment.
• Proficient in Microsoft Office applications, including Excel 1 (data entry, formulas, charts, and basic data analysis), Word (document creation and revision), Outlook, and Teams.
• An understanding of complex hardward equipment and the ability to troubleshoot electromechanical assemblie ( identify root causes using structured problem-solving methods).
• Demonstrated understanding of Good Documentation Practices (GDP) and document control requirements.

Demonstrates expertise in electromechanical assembly evaluation, troubleshooting, and process validation while ensuring compliance with ISO 13485 and FDA regulations. Proficient in creating and maintaining documentation and standard operating procedures to support manufacturing efficiency and quality.

• Electromechanical Assembly Evaluation
• Process Validation (IQ/OQ/PQ)
• Good Documentation Practices (GDP)
• Troubleshooting and Root Cause Analysis
• Microsoft Office Proficiency

• Electromechanical Assembly Repair
• Data Collection and Analysis
• Manufacturing Process Improvement
• Standard Operating Procedure (SOP) Writing
• Engineering Change Records Management

• Collaboration with Production Teams
• Effective Communication

• ISO 13485
• MDSAP
• FDA Regulations
• CAPA Activities
• Risk Management

• Microsoft Excel
• Microsoft Word
• Microsoft Outlook
• Microsoft Teams