Design Engineer

SHL Medical is a world-leading solution provider in the design, development, and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto-injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018, with sites in the USA, Taiwan, and Sweden.

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
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