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Product Support Engineer

Orange County Metro Area, CA

Posted: 07/09/2018 Job Type: Engineering Job Number: JN -072018-22002
Description:

This positon will provide needed support to Manufacturing project requests (cost improvements, obsolescence, corrective actions) for electromechanical/mechanical post market products: Analyze and trouble shoot design and process changes, document impact on product design to support electrical/electromechanical design and process changes, complaint and risk analysis, technical file and product compliance documentation for Surgical Instrumentation products.

This position will also support project activities required for compliance to new European Medical Device Regulation (MDR), including managing and reporting technical product data, materials remediation, labeling updates and technical file updates (required to maintain European registration (CE mark) and will work to maintain product compliance to existing and future regulations and product test standards and reporting (EN, ISO, etc.)

Skills:

5+years of experience ideally in the medical device industry
Experience with product Verification & Validation
Medical Device Design Control including risk assessment, management and reporting
Experience with Corrective and Preventative Action (CAPA) including root cause analysis, problem solving and redesign of devices to meet requirement
Familiar with PRO-E and other Windchill product data management applications is preferred
Excellent written and spoken communication skills
Proficient in MS Office applications

Education:

Bachelors in Engineering Electrical, Electromechanical, Mechanical Engineering preferred

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