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Descripción y detalle de las actividades
SUMMARY: •Be an important member of a cross functional team responsible to assess product design files, identify and resolve technical gaps in preparation for Regulatory submissions. You will be critical R&D engineer working closely with subject matter experts to investigate and verify technical information, generate justifications, execute testing protocols and write reports. ESSENTIAL DUTIES AND RESPONSIBILITIES: • Create performance verification protocols and write reports. • Execute test protocols, summarize data, analyze and make conclusions. • Investigate design history files, design specifications, test reports and manufacturing documentation to provide accurate and timely technical information for Regulatory submissions. • Work closely with subject matter experts to development technical justification reports. • Prepare product drawings and illustrations for Regulatory submission. • Attend appropriate meetings – technical and core team, providing updates as required.
Experiencia y requisitos
• Bachelors in Engineering required. BS in Mechanical or Materials Engineering preferred. • 3-4 years engineering experience in medical device product development and/or manufacturing environment preferred. • Experience with mechanical characterization methods such as tensile, compression or modulus testing preferred. • FDA Quality System Regulation Part 820 and ISO 13485 experience preferred. •Working knowledge of SolidWorks CAD software is preferred.
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