3 часа назад
Senior Electrical Engineer (Medical Devices)
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Senior Electrical Engineer (Medical Devices): Owning electrical and electromechanical system performance for surgical-device manufacturing with an accent on production support, electrical design changes, automated test systems, and regulated validation. Focus on troubleshooting failures to the component level, leading cross-functional engineering projects, implementing corrective actions, and ensuring compliance with FDA QSR, ISO 13485, and ISO 14971.
Location: Allen, Texas, United States; onsite lab and production-floor work required. Travel to supplier or manufacturing sites may be required up to 10%.
Company
Corporation manufactures surgical solutions for the medical industry in a regulated medical-device environment.
What you will do
- Own the electrical and electromechanical performance of PCBAs, sensors, test systems, and software-controlled subsystems.
- Lead medium-to-large cross-functional projects, managing scope, schedules, risks, deliverables, and execution.
- Provide hands-on production support by resolving electrical failures, test issues, yield losses, and line stoppages.
- Troubleshoot issues to the component level using schematics, BOMs, test data, oscilloscopes, logic analyzers, and multimeters.
- Execute ECOs, design changes, sustaining engineering, validation, qualification, and automated electrical test strategies.
- Partner with Quality, Operations, Supply Chain, Field Service, and suppliers while mentoring engineers and technicians.
Requirements
- Bachelor’s degree in Electrical Engineering, Systems Engineering, Mechatronics, or a related discipline.
- 8–10 years of electrical or electromechanical engineering experience in manufacturing or a regulated environment.
- Experience independently leading projects while supporting active production lines.
- Strong system-level understanding and advanced board-, subsystem-, and system-level troubleshooting skills.
- Experience with ECAD tools such as Altium, OrCAD, PADS, or equivalent, plus electrical test equipment and automated test systems.
- Ability to produce technical reports, validation documentation, and ECO documentation and communicate across functions.
Nice to have
- Master’s degree in a relevant discipline.
- Medical-device experience.
- Experience with LabVIEW-based test systems, IQ/OQ/PQ/PPQ validation, FMEA, Fault Tree, A3, and statistical analysis.
Culture & Benefits
- Work across laboratory and production-floor environments with ESD precautions.
- Support continuous improvement through standard work, structured problem solving, and waste reduction.
- Collaborate with Quality, Operations, Supply Chain, Field Service, suppliers, engineers, and technicians.
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