SDS de México, S. de R.L. de C.V.

Ingenieros de Procesos

SDS de México, S. de R.L. de C.V.

Ene. 15

Mexicali, Baja California

Giro

Maquiladora (Export.)

Actividad principal

Industria de manufactura líder en la fabricación de instrumentos médicos dentales.

Número de empleados

1700

Sitio Web corporativo

Dirección

Circuito Sur Carr. a San LRC. Km. 13.5

Colonia o fraccionamiento

Parque Industrial Nelson

Ciudad

Mexicali, Baja California

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.

Número de vacantes

2

Área

Ingeniería

Contrato

Permanente

Turno

Diurno

Jornada

Tiempo Completo

Horario

Lunes a Viernes de 6:00 a.m. a 3:30 p.m.

Estudios

Carrera Profesional

Inglés

Hablado: 100%, Escrito: 100%

Sexo

Indistinto

Edad

18 - 65 años