Descripción y detalle de las actividades
- Developing mechanical designs and prototypes for medical devices, ensuring compliance with ISO 13485 and FDA regulations.
- Creating and reviewing engineering drawings and technical documentation according to **GD&T; ASME Y14.5-2018**, with additional knowledge of ASME Y14.43 for gages and fixtures being a plus.
- Conducting structural analysis, solid mechanics, Computational Fluid Dynamics (CFD), and Finite Element Analysis (FEA) to validate designs.
- Designing test fixtures and developing Design of Experiments (DOE) for product validation.
- Collaborating with cross-functional teams and participating in continuous improvement and industrial engineering initiatives.
- Preparing and managing technical documentation in English, ensuring regulatory and quality compliance.
Experiência y requisitos
**Education and Experience**:**
- Bachelor’s or Master’s degree in Mechanical, Mechatronics, Biomedical Engineering, or related fields.
- Minimum of 5 years of experience in the medical device industry, involved in design and/or manufacturing activities under ISO 13485 Design Controls.
- Experience in product design and manufacturing knowledge (sheet metal, injection molding, extrusion, 3D printing, CNC machining, lathe operations).
- Experience with continuous improvement processes and industrial engineering methodologies.




**Technical Skills**:
- CAD software (SolidWorks, Onshape, or equivalent) - 5+ years of experience.
- DFMA (Design for Manufacturing and Assembly).
- GD&T; ASME Y14.5-2018; additional knowledge of ASME Y14.43 is a plus.
- Structural analysis, solid mechanics, CFD, and FEA.
- ISO 13485 Design Controls and design of fixtures/DOE.
**Soft Skills**:
- Sense of urgency and strong organizational skills.
- Leadership, supervisory experience, and teamwork.
- Effective communication and relationship-building with internal and external stakeholders.
- Strong process and people management skills.
**Additional Requirements**:
- Full professional proficiency in English (written and spoken).
- US Visa and Mexican passport preferred.
Beneficios
- Beneficios de acuerdo a la LFT
- Confiable de vida
- Transporte
- Uniforme
- Utilidades garantizadas
- Caja de ahorro
- Servicios medicos en planta
- Comedor
**Número de vacantes** 1
**Área** Diseño
**Contrato** Permanente
**Modalidad** Presencial
**Turno** Diurno
**Jornada** Tiempo Completo
**Horario**
- Tiempo completo
**Salario mensual neto** $60,000 - $65,000 MXN
**Estudios** Carrera con título profesional
**Inglés**Hablado: Avanzado, Escrito: Avanzado
**Disponibilidad p. viajar** No

📌 Lead Mechanical Design Engineer - Medtech (Tijuana)
🏢 Importante empresa
📍 Tijuana