Descripción y detalle de las actividades
- Purpose of the position: The ME will be responsible for supporting production activities in the medical device industry including yield improvement initiatives, product disposition, continuous improvement activities, assembly procedure development, and process validations.
Additional responsibilities will include the transfer of new products and processes into manufacturing, process optimization, mistake proofing, process risk analysis, design reviews and provide input on design for manufacturing.
Key Tasks & Responsibilities: - Create, write, and execute process validations.
- Participate and execute validation strategy.
- Lead Projects with some supervision.
- Support and lead continuous improvement activities and yield improvement initiatives.
- Develop, update pFMEA.
- Support production on non-conformances, determine root cause and develop solutions.
- Write engineering technical reports.
- Experience with equipment specification, equipment troubleshooting, maintenance procedures, test protocols and validation.
- Experience in developing and implementing production processes (preferred) - Experience with micro assembly, electronic manufacturing, laser welding and silicone molding (preferred) - Experience with Scrum or Kanban Methodology (preferred).
- Establish, Other duties as assigned.
Experiência y requisitos




- Minimum Bachelor's Degree in appropriate engineering field of study or equivalent work experience.
Mechanical or Mechatronic engineering or related Science.
- Visa B1/B2 for travel to USA.
- 2-5 years' experience as a manufacturing or mechanical engineering in the medical device industry.
- Desirable: Class 3 Medical Device Experience Professional Competencies - Strong experience with process validation - IQ, OQ, PQ - Familiarity with processes such as FMEA, CAPA and Standard Works.
- Experience with statistical concepts.
- Project Management (Small project - preferred).
Desirable: - Six Sigma certification - Continuous improvement experience (Kaizen, Gemba, Daily Management, etc.) - TUV and FDA regulatory documentation experience IT skills - Proficient in Microsoft office, Word, Excel, PPP, Outlook - Experience with Visio, Microsoft Project, Jira (preferred).
- AutoCAD (Basic).
- Minitab (preferred).
Desirable: PLM / Solidworks/ PRO-E a plus English : 85%
Beneficios
- Beneficios de acuerdo a la LFT
- fondo de ahorro
**Número de vacantes** 1
**Área** Ingeniería
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Horario**
- Tiempo completo
- Lunes a viernes
- Turno Matutino
**Estudios** Carrera con título cualificado
**Inglés**Hablado: Avanzado, Escrito: Avanzado
**Edad** ******* años
**Disponibilidad p.
viajar** Si

📌 Manufacturing Engineer (Mexicali)
🏢 Sonova
📍 Mexicali