AS Engineer - #250564

Analytical Sciences Engineer

SHL Medical is the 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 Sweden, Taiwan, and the United States.

Job Overview

Execute tests, document & analyze test data, write protocols, procedures, equipment work instructions, test instructions.

Main Responsibilities

• Execute Design Assessment (DA), Design Verification (DV), Test Method Validation (TMV) and Test Method Transfer (TMT) tests.
• Run tests using lab test equipment such as Instron, vibration machine, environmental chambers, etc.
• Performs root cause analysis of non-conformance findings and will be a key member of a cross functional team that will conduct “out of specification investigations”.
• Record and analyze test results against requirements
• Prepare operational procedures, work instructions and test instructions
• Help with/initiate document updates
• Assist the QA Engineer in all quality activities to support the Analytical Sciences department
• Comply with all quality, safety, and work rules and regulations
  
  

Skills and Qualification

• Preferred B.E. in Biomedical Engineering/Mechanical Engineering or any relevant branch of study.
• 0–2-year experience within the medical device industry is required
• Candidate must be familiar with current Design Verification practices and guidelines including those required / outlined by the FDA, ISO, and ASTM
• Knowledge of Good Laboratory Practices, Good Manufacturing Practices & Good Documentation Practices
• Proficiency in Microsoft Excel and Microsoft Word is a must
• Able to communicate effectively and work within cross-functional teams.
  
  

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