Ingeniero de Manufactura II- experiencia en cables y arneses

Amphenol CMT - Critical Medical Technologies; Tijuana; Vor Ort; MXN 360.000 - 540.000; Vollzeit

Zusammenfassung

Amphenol CMT - Critical Medical Technologies in Tijuana seeks a hands‑on manufacturing engineer to develop, implement, and optimize processes that enhance efficiency and product quality. You will collaborate with cross‑functional teams and drive process improvements across the production floor.

Requirements include an engineering degree with 3+ years of industry experience, advanced English, and knowledge of FDA/ISO 13485 standards. CAD tooling and ERP familiarity are valued assets for this role.

Qualifikationen

• Engineering degree and >3 years industry experience (or >10 years in a related role).
• Advanced English proficiency; strong communication skills.
• In-depth knowledge of FDA and ISO 13485 medical device standards.
• CAD proficiency using AutoCAD or SolidWorks; ERP experience a plus.

Aufgaben

• Develop, implement, and optimize manufacturing processes and systems to improve efficiency and product quality.
• Collaborate with cross-functional teams and lead process improvement initiatives.
• Support New Product Introductions, process transfers, and sustaining engineering.

Kenntnisse

Troubleshooting

Cross-functional collaboration

Project management

Lean manufacturing

Six Sigma

Communication skills

ERP experience

Ausbildung

Bachelor of Science in Engineering/Science

Tools

AutoCAD

SolidWorks

ERP systems

Jobbeschreibung

Responsible for the development, implementation, and optimization of manufacturing processes and systems to improve efficiency, reduce costs, and ensure product quality. This position involves collaboration with cross-functional teams, project management, and continuous improvement initiatives, progressively increasing in responsibility.

• Experience in the medical device industry, preferably working under ISO 13485 and/or FDA regulations.
• Hands-on experience in cable assembly manufacturing processes, including Wire Cutting, Wire Stripping, Crimping, Soldering, Heat Shrink, Connector Assembly, Ultrasonic Welding, Pull Testing, Continuity Testing, Hi-Pot Testing, and Overmolding.
• Experience with Process Validation (IQ/OQ/PQ).
• Experience supporting New Product Introductions (NPI), Process/Line Transfers, and Sustaining Engineering activities.
• Knowledge of Root Cause Analysis (RCA), CAPA, NCMR, 8D, PFMEA, Control Plans, Yield Improvement, and Scrap Reduction.
• Experience with fixtures, tooling, poka-yokes, automation, and semi-automation solutions.
• Hands-on profile with strong troubleshooting skills and direct experience supporting production floor operations.

• Engineer II - Education: Bachelor of Science in engineering / science with >3 years industry experience or >10 years in related technical role.
• Inglés avanzado.
• In-depth knowledge of FDA regulations, ISO 13485, and other relevant standards for medical device manufacturing.
• Proficient in MS Office (Word, PowerPoint, Outlook, Excel) for all levels.
• Knowledge and experience with CAD software for 2D and 3D modeling, such as AutoCAD, SolidWorks, or similar, increasing in complexity with level.
• Strong communication skills, capable of effectively presenting information and responding to questions from groups of managers, clients, customers, and the general public.
• For higher levels, demonstrated ability in project management software and methodologies, lean manufacturing principles, Six Sigma certification, and experience with ERP (Enterprise Resource Planning) systems.
• Specific knowledge related to the manufacturing field, such as CNC programming, robotics, automation, and process simulation, is highly valued.
• Lean Six Sigma Green Belt certification desirable.
• Project Management Professional (PMP)® desirable Certification.