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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