AS Engineer
Deerfield Beach, United States of America
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
