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.