Descripción y detalle de las actividades- Creation, revision and/or approval of manufacturing and engineering documentation, including: Engineering Change Orders (ECO's, BCO's, NCO's, MCO's, etc.) - Work instructions (Manufacturing Process Instructions, Acceptance criteria, etc.) Operating procedures (SOP's, DOP's, etc.) - Documenting and Performing investigation, address root cause, and establishing CA/PA on any variances, or concerns on all aspects of the manufacturing process through current quality notification processes (VR's, NCR's, PL's, etc.). - Supporting multifunctional teams on the resolution of issues related to supplier quality issues. Execute Engineering Builds Reviews (EBR). - Update and revise Manufacturing Process Instructions (MPIs) to ensure accuracy and completeness. - Active participant in quality improvement initiatives, providing feedback to find and solve root cause of problems. - Responsible for developing and maintaining compliance with the quality system. Address production line support as issues arise. - Engineering Leadership on new product, new processes, or improvements projects. This includes coordination and execution of validations and lead cross functional teams.Experiência y requisitos2 years of experience in Manufacturing and Process Engineering in Medical Device Industry with wide range of experience in validation of new or transferred equipment and processes (IQ/OQ/PQ/PPQ/Gage R&R). Hands-on experience working with cross functional teams in Corrective and Preventive Action (CAPA), Failure Mode Effect Analysis (Process and Design), Control Plans, Root Cause Analysis, DMAIC methodology, Six Sigma Projects, 5S principle, Lean Manufacturing. Thorough understanding of cGMP 21 CFR part 210 & 211, part 820 QSR, FDA guidance, and ISO 13485. Experience working on supporting, maintaining, improving, problem-solving and further developing the manufacturing line as needed for sustaining production. CAD/CAM: Auto CAD, Mastercam, Solidworks Microsoft Project Oracle SAP Minitab PLCOrganizaciónIntuitive Surgical, S. de R.L de C.V.GiroMaquiladora (Export.)Actividad principalProductos médicos para cirugía.Número de empleados1500/registro**Área** Ingeniería**Contrato** Permanente**Turno** Nocturno**Jornada** Tiempo Completo**Horario** Jueves a Domingo 6pm a 6am, Lunes a Jueves 6pm a 6am (4 x 3)**Estudios** Titulo Profesional**Inglés **Hablado: 90%, Escrito: 90%**Sexo** Indistinto