Job Summary
The Equipment Engineer (Medical EMS) is responsible for the technical performance and regulatory compliance of SMT manufacturing assets. This role bridges the gap between hardware maintenance and stringent medical quality standards. You will ensure that every piece of equipment is installed, validated, and maintained according to ISO 13485 and FDA-level documentation standards, ensuring that our medical product manufacturing remains uninterrupted and audit-ready.
Job Description
1. Technical Documentation & Compliance (Primary Focus)
- Validation Lifecycle: Draft, execute, and finalize Installation Qualification (IQ) protocols. Ensure all equipment meets the specific tolerances required for medical-grade PCBA.
- Standard Operating Procedures (SOPs): Create and update detailed Equipment Procedures and Calibration Procedures that satisfy high-level EMS medical audits.
- Good Documentation Practices (GDP): Maintain a zero-error approach to all logs, ensuring every signature, date, and data point adheres to medical industry record-keeping standards.
- Audit SME: Act as the technical lead during client and regulatory audits, defending equipment maintenance records and validation protocols.
2. SMT Equipment Management
- Preventive Maintenance (PM): Schedule and perform PM for SMT lines (Screen Printers, SPI, Pick-and-Place, Reflow, AOI), ensuring all actions are logged in compliance with the Quality Management System (QMS).
- Calibration Oversight: Manage the calibration cycle for critical equipment components to ensure accuracy in medical product assembly.
- Yield Improvement: Analyze equipment performance data to reduce defects, ensuring that hardware stability contributes to high first-pass yields.
3. Medical Product Integration
- Process Alignment: Work closely with NPI (New Product Introduction) teams to ensure SMT equipment is optimized for the specific requirements of new medical devices.
- CAPA Support: Investigate equipment-related non-conformances and implement Corrective and Preventive Actions (CAPA) to prevent recurrence in the production of sensitive medical electronics.
Job Requirements
- Industry Experience: Minimum 3+ years in an EMS environment, with specific exposure to Medical Device manufacturing (ISO 13485 standards).
- Documentation Mastery: Proven ability to write technical IQ/OQ protocols and formal Equipment/Calibration procedures from scratch.
- SMT Expertise: Comprehensive knowledge of SMT line machinery and the software used to program and monitor them.
- Regulatory Knowledge: Deep understanding of GDP (Good Documentation Practices) and how they apply to equipment logs in a medical context.
- Analytical Skills: Proficiency in MS Excel for data-driven maintenance tracking and MS Word for professional technical reporting.
