Electrical Engineer

Assembly Tester

Location:

Milpitas, CA – All 5 days onsite

Duration: 6+ months

Skills:

Assembly Tester, Manufacturing Medical Devices, Electrical Engineer

Experience Level: Senior-Level (7+ Years)

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.

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.
• 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.
• 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.

• 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.

Seniority level:
Senior-Level (7+ Years)

Employment type:

Contract

Job function:
Information Technology

Industries: IT Services and IT Consulting