Manufacturing Engineer (Experiencia Área Medica)

Mam de la Frontera, S.A. de C.V.; Tijuana; Presencial; MXN 732,000 - 1,100,000; Jornada completa

Descripción de la vacante

A leading medical products manufacturer in Tijuana is seeking an experienced professional in manufacturing and design of medical products. The role involves driving process improvements, resolving technical issues, and ensuring adherence to FDA quality system regulations. Ideal candidates will have over 3 years of experience in manufacturing single-use medical devices and fluency in English. Competitive salary and opportunities for growth are available.

Formación

• 3+ years of experience in manufacturing/design of medical products.
• Strong background in disposable/single-use medical devices.
• Experience with high volume manufacturing assembly processes.

Responsabilidades

• Drive process and product improvement activities for product quality.
• Resolve technical issues to ensure product supply is not impacted.
• Identify and implement continuous improvement projects.

Conocimientos

Statistical techniques

Lean manufacturing tools

Six Sigma

Process improvement

Technical leadership

English fluency

Educación

B.S. in Industrial Engineering or similar technical field

Herramientas

Microsoft Office Suites

Minitab

Visio

AutoCAD

SolidWorks

Descripción del empleo

Responsibilities

• Drive process and product improvement activities to promote product quality, overall manufacturing cost, efficiency and manufacturability using statistical techniques, lean manufacturing tools, Six Sigma, tool & fixture design, and DOE for process and equipment
• Resolve technical issues and provide production support to quickly address production issues in a high volume low mixed manufacturing environment to ensure product supply is not impacted.
• Identify and implement continuous improvement projects related to first pass yield, cycle time reduction, product reliability, capacity improvements, and cost reduction.
• Provides technical leadership and Design for Manufacturability input to product development teams.
• Work closely with R&D through development and production release of new products to manufacturing and meeting cost targets.
• Responsible for developing engineering and manufacturing documentation (Work instructions, procedures, BOMs, Routings, PFMEA, Rework instructions, drawings, etc.).
• Responsible for process and equipment validation (IQ/OQ/PQ/MSA activities).
• Work with PMO team to adhere with project schedules and finding creative ways to shorten timelines.
• Initiate corrective and preventive action in accordance with company CAPA procedure.
• Engage with external suppliers to ensure project objectives are met and that product performance meets customer and quality requirement

Required Qualifications

• B.S. in Industrial Engineering or similar technical field.
• 3+ years of experience in the manufacturing/design of medical products, with a strong background in the manufacturing & development of disposable/single use medical devices.
• Experience with high volume manufacturing assembly processes.
• Strong knowledge of FDA quality system regulations, GMP, and ISO 13485 requirements.
• Strong track record in design, testing, and manufacturing process development.
• Strong analytical and technical skill set based on engineering analysis fundamentals.
• Demonstrated ability to find creative ways to meet tight timelines.
• Experience managing engineering projects.
• NPI experience.
• Proficient in Microsoft Office Suites, Minitab, Visio, AutoCAD and SolidWorks.
• Must be able to communicate fluently in both written and spoken English.