Job Description

Role: 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.

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