Medical Device Product Development Engineer

AMETEK, Inc.; Reynosa; Presencial; MXN 1.276.000 - 1.872.000; Jornada completa

Descripción de la vacante

AMETEK, Inc. is seeking a PDE Engineer to lead multi-project development of advanced medical components in a high-reliability environment. The role requires translating VOC and market needs into robust designs and coordinating with Sales, CAS, and suppliers to align with the technology roadmap.

You will develop concepts, create prototypes, and manage costs and schedules while ensuring compliance with ISO 13485 and FDA standards. Travel up to 10% and bilingual English/Spanish are required.

Formación

• Bachelor’s degree in Mechanical Engineering, Materials Science, or related engineering discipline (or equivalent).
• 3+ years of experience in product design, development, and manufacturing environments.
• Demonstrated ability to manage multiple engineering projects simultaneously in a structured development environment.
• Experience with manufacturing technologies: Crimping, Iron Soldering, Cutting/Stripping, Molding, IPC 620/610/J-STD-001, Laser printing.
• Knowledge of ISO 13485 and FDA regulations.
• Strong skills in AutoCAD, SolidWorks, Excel, Word, and PowerPoint.
• Excellent written and verbal communication; interface with customers and cross-functional teams.

Responsabilidades

• Lead multiple transfers and new product development projects from concept through production release.
• Translate VOC, market requirements, and business objectives into robust product designs.
• Collaborate with Sales and CAS to define product requirements and align developments with the roadmap.
• Develop product concepts, detailed designs, and prototypes using solid engineering principles.
• Prepare project cost estimates, schedules, and technical risk assessments.
• Control material and labor variance against standards.
• Support prototype fabrication and process development activities as needed.
• Coordinate with local and regional suppliers for tooling and fixtures; automate where feasible.
• Plan and execute design verification and validation testing (IQs, OQs, PQs, FAI).
• Evaluate materials, processes, tolerances, and design tradeoffs to optimize performance and manufacturability using SPC tools.
• Create and release engineering documentation including specs, BOMs, visuals, test plans, and building instructions.
• Monitor yields and address top offenders; support transition of new products into production.
• Communicate project status, risks, and mitigation plans to stakeholders; ensure on-time delivery.
• Apply engineering judgment to determine readiness for project closure; support continuous improvement.

Conocimientos

Project management

Cross-functional collaboration

Communication

Bilingual English/Spanish

Educación

Bachelor’s degree in Mechanical Engineering or Materials Science

Herramientas

AutoCAD

SolidWorks

MS Excel/Word/PowerPoint

ISO 13485 & FDA knowledge

Fabrication/Manufacturing processes

IPC 620, 610 & J-STD-001

Laser printing

Descripción del empleo

AMETEK, Inc. is seeking a PDE Engineer to lead multi-project development of advanced medical components in a high-reliability environment. The role requires translating VOC and market needs into robust designs and coordinating with Sales, CAS, and suppliers to align with the technology roadmap.

You will develop concepts, create prototypes, and manage costs and schedules while ensuring compliance with ISO 13485 and FDA standards. Travel up to 10% and bilingual English/Spanish are required.