Mechanical/Manufacturing Engineer, Medical Devices (Hybrid)

Dilon Technologies; Newport News (VA); Híbrido; USD 80.000 - 110.000; Jornada completa

Descripción de la vacante

Dilon Technologies in Newport News, Virginia, is seeking a Mechanical / Manufacturing Engineer to design the mechanical side of next-generation medical devices and ensure reliable scale-up. This hybrid role splits time between new product development and manufacturing engineering in support of production.

You will collaborate across systems, electrical, software, and test teams, guide design transfer to production, and drive continuous improvement on yield and cost while adhering to 21 CFR 820

Formación

• Bachelor's degree in Mechanical Engineering or related field.
• 5+ years of mechanical design experience, preferably in medical devices.
• Hands-on manufacturing engineering experience with assembly processes, fixtures, and production support.
• Proficiency in SolidWorks, GD&T, and tolerance analysis.
• Familiarity with design controls and quality systems (21 CFR 820, ISO 13485).
• Experience with IQ/OQ/PQ process validation and root cause analysis tools.
• Knowledge of machining, injection molding, sheet metal, and electromechanical assembly.

Responsabilidades

• Lead mechanical design from concept to production release for next-generation medical devices.
• Develop and maintain assembly processes, fixtures, and work instructions for production builds.
• Lead design transfer, pilot builds, and production test strategy.
• Support the production floor with issue resolution and CAPA.
• Collaborate with systems, electrical, software, and test engineers to ensure robust designs.

Conocimientos

Mechanical design

Manufacturing engineering

CAD

GD&T

Tolerance analysis

Design for manufacturing

Documentation writing

Regulatory knowledge (21 CFR 820 / ISO

Educación

Bachelor's degree in Mechanical Engineering

Herramientas

SolidWorks

Arena PLM

Descripción del empleo

Dilon Technologies in Newport News, Virginia, is seeking a Mechanical / Manufacturing Engineer to design the mechanical side of next-generation medical devices and ensure reliable scale-up. This hybrid role splits time between new product development and manufacturing engineering in support of production.

You will collaborate across systems, electrical, software, and test teams, guide design transfer to production, and drive continuous improvement on yield and cost while adhering to 21 CFR 820