• 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.
• Bachelor’s 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.
• Working knowledge of SolidWorks CAD software is preferred
• Ability to read, analyze, interpret, create, and meet product specifications, technical procedures, and worldwide governmental regulations.
• Ability to develop test protocols, execute testing, statistically analyze data, and develop conclusions.
• Ability to write technical reports and justifications.
• Excellent interpersonal skills works well within a team, able to collaborate with and influence others.
• Excellent oral and written communication skills.
|Edad||Mayor de 28 años|
|Horario||Lunes a Viernes de 6:00 a.m. a 3:30 p.m.|