Design Engineer, Medical Drug-Delivery Devices

SHL Medical AG; Deerfield Beach (FL); Presencial; USD 75.000 - 110.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Competitive compensation package

Modern facilities and technologies

Challenging assignments in a global, 0

Descripción de la vacante

SHL Medical AG is seeking a Design Engineer to develop drug delivery devices, including design, prototyping, analyses, and testing. The role requires collaboration with cross-functional teams, direct communication with customers and manufacturing, and travel more than 10% of the time.

You will also support regulatory filings for combination products. Responsibilities include planning tests, conducting design verifications, root-cause investigations, and aiding commercialization and scale-up

Formación

• 2-4 years of experience in Design.
• BS Mechanical Engineering/BS Biomedical Engineering.
• Proficient in mechanical design (SolidWorks preferred).
• Proficient at technical analyses including statistical analysis and tolerance analysis.
• Proficient at performing Finite Element Analysis.
• Knowledge of manufacturing processes including injection molding.
• Knowledge of risk management processes including FMEA.
• Knowledge of regulations and standards including: 21 CFR Part 820, ISO 13485, ISO 11608, ISO 14971.
• Proficient in oral and written communication.
• Demonstrates good judgment as well as cultural, social, and environmental awareness.

Responsabilidades

• Execute design and development of drug delivery devices following design controls.
• Plan testing for characterization, design feasibility, and Design Verification.
• Perform technical analyses including statistical analysis and tolerance analysis.
• Lead root cause investigations.
• Support commercialization and scale-up efforts.

Conocimientos

Design experience

Mechanical design

Statistical analysis

Root cause analysis

Educación

BS Mechanical Engineering

BS Biomedical Engineering

Herramientas

SolidWorks

Finite Element Analysis

Statistical analysis

Descripción del empleo

SHL Medical AG is seeking a Design Engineer to develop drug delivery devices, including design, prototyping, analyses, and testing. The role requires collaboration with cross-functional teams, direct communication with customers and manufacturing, and travel more than 10% of the time.

You will also support regulatory filings for combination products. Responsibilities include planning tests, conducting design verifications, root-cause investigations, and aiding commercialization and scale-up