Organización
SDS de México, S. de R.L. de C.V.
Corporativo
Danaher
Giro
Maquiladora (Export.)
Actividad principal
Industria de exportación líder en la fabricación de instrumentos médicos dentales.
Empleados
1700

Ingenieros de Procesos

Descripción y detalle de las actividades

• 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

• 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.

Compartir vacante por:
Información Adicional
Vacantes 2
Contrato Permanente
Área Ingeniería
Estudios Carrera Profesional
Turno Diurno
Sexo Indistinto
Edad Mayor de 28 años
Horario Lunes a Viernes de 6:00 a.m. a 3:30 p.m.
Jornada Tiempo Completo
Sueldo Según aptitudes
Idioma Hablado Escrito
Inglés 100% 100%

Contacto
Lic. Cristina Rincón
Teléfono
(686) 580-4601
Dirección
Circuito Sur Carr. a San LRC. Km. No. 13.5
Colonia ó fracc.
Parque Industrial Nelson
Ciudad
Mexicali, Baja California