AS Engineer

AS Engineer SHL Medical Assembly&Servc LLC Deerfield Beach, FL Job Details 1 day ago Benefits Career development plan Qualifications ASTM standards GLP ISO standards Spreadsheets Word embeddings Biomedical regulatory compliance Productivity software FDA regulations Full Job Description SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth. Together, we empower our people to develop solutions that make a meaningful difference in the lives of millions of patients while fostering a supportive, inclusive, and dynamic workplace for our colleagues. 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. 1-2-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