Assembly Tester - Electrical Engieer

Assembly Tester Location - Milpitas, CA - All 5 days onsite Duration - 6+ mos Skills - Assembly Tester, Manufacturing Medical Devices, Electrical Engineer Experience Level Senior-Level (7+ Years) Job Summary We are seeking an experienced Manufacturing Electrical Engineer with a strong background in medical device manufacturing to support electrical assembly, testing, supplier management, and product end-of-life activities. The ideal candidate will work cross-functionally with R&D, Quality, Supply Chain, and Manufacturing teams to ensure robust, compliant, and scalable production processes while meeting regulatory and quality standards. Key Responsibilities Manufacturing & Assembly Support • Develop, optimize, and sustain electrical manufacturing and assembly processes for medical devices. • Provide hands-on engineering support for electrical assemblies, wiring, PCBAs, test fixtures, and production equipment. • Troubleshoot and resolve electrical and manufacturing issues to minimize downtime and improve yield. • Support process validations (IQ/OQ/PQ) and continuous improvement initiatives. Testing & Validation • Define and implement electrical test strategies for in-process, final, and reliability testing. • Develop and maintain test procedures, test fixtures, and automated test systems. • Analyze test data, identify root causes of failures, and implement corrective actions. • Ensure compliance with FDA, ISO 13485, IEC, and other applicable medical device standards. Supplier & Component Management • Collaborate with Supply Chain and Quality teams to manage electrical component and supplier performance. • Support supplier qualification, audits, and technical reviews. • Drive resolution of supplier-related electrical and quality issues. • Lead cost reduction, alternate sourcing, and component obsolescence mitigation efforts. End-of-Life (EOL) & Sustaining Engineering • Lead and support end-of-life (EOL) planning for electrical components and products. • Manage PCN/ECN activities, last-time buys, and redesigns due to obsolescence. • Ensure smooth transition of products through lifecycle phases while maintaining compliance and supply continuity. Documentation & Compliance • Create and maintain manufacturing documentation including work instructions, schematics, BOMs, test procedures, and validation reports. • Ensure adherence to Design Controls, Change Management, and Quality System requirements. • Support internal and external audits as required. Required Qualifications • 7+ years of experience in manufacturing or sustaining engineering within the medical device industry. • Strong experience with electrical assembly, testing, and troubleshooting in a regulated environment. • Proven knowledge of medical device regulations (FDA QSR, ISO 13485, IEC 60601 preferred). • Experience with supplier management and component lifecycle/EOL management. • Ability to read and interpret schematics, wiring diagrams, and technical specifications. • Strong problem-solving, communication, and cross-functional collaboration skills.

Created: 2026-03-30