AS Engineer

Summary

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. The AS Engineer will execute tests, document and analyze test data, and prepare operational procedures while ensuring compliance with quality and safety regulations.

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

• 1–2-year experience within the medical device industry
• 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
• Able to communicate effectively and work within cross-functional teams
• B.E. in Biomedical Engineering/Mechanical Engineering or any relevant branch of study

Qualifications

Must Haves

• 1–2-year experience within the medical device industry
• 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
• Able to communicate effectively and work within cross-functional teams

Nice to Haves

• B.E. in Biomedical Engineering/Mechanical Engineering or any relevant branch of study

Benefits

• 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