Design Engineer

Job Overview

The Design Engineer carries out development activities for medical devices, including design, prototyping, technical analyses, and testing. The Design Engineer collaborates closely with cross-functional project teams to ensure that designs meet user needs, and quality requirements, and consider manufacturability. The Design Engineer will communicate directly with customers and manufacturing teams and will be required to travel >10% of the time. The Design Engineer will also support regulatory filings for combination products.

Main Responsibilities

• 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

Skills And Qualification

• 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

We Offer

• Competitive compensation package
• Modern working environment with state-of-the-art facilities and technologies
• Challenging assignments in a fast-growing and innovative industry
• Position in a dynamic, international team of highly skilled professionals
• Various opportunities for personal and professional development within a global organization