IW
Assembly Tester - Electrical Engieer
Info Way Solutions LLC
- 🇺🇸 United States
- On-site
- Senior
- 9 months ago
- IEC
- Change Management
9 months ago
Not enough detail in this posting to match
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.
Assembly Tester - Electrical Engieer · Info Way Solutions LLC