Responsible for supporting and managing complex chemistry related projects in medical device product development, production, and maintenance. Design and optimize chemical processes to large-scale industrial manufacturing, including developing chemical flow diagrams and determining equipment specification while considering safety, efficiency, cost and environment impact. Guide and mentor the chemistry manufacturing team and other departments in resolving chemical manufacturing and production issues, improving engineering and project systems, and identifying and resolving system deficiencies. Job duties:Lead improvement/development/transfer of chemical projects. Support existing chemical manufacturing processes, new products, product changes, line extensions, enhancements, and related tooling and fixture development and/or improvements. Review and develop manufacturing documents (e.g., MP, Routers, BOM, etc.). Draft and execute validation of chemistry products, equipment, and processes. Lead collaboration with other departments to solve manufacturing production issues. Support equipment maintenance program and monitor sustainment health metrics. Analyze data and improve processes to ensure robust/repeatable manufacturing processes. Confer with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems, and develop processes. Lead process validation and product transfer activities across different manufacturing facilities. Investigate and test product processes and identify and review system deficiencies (e.g., NCR’s, DC, EO’s, etc.). Identify and execute improvements, issues, or any process requirements with minimum supervision. Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization. Perform additional duties as assigned. Bachelor of Science in Chemical Engineering, Chemistry, Chemical Sciences, or a related field of study. A minimum of four (4) years of relevant chemical, pharmaceutical, and/or medical device manufacturing experience. Strong written and verbal communication skills. Ability to prioritize and meet deadlines in a timely manner. Proficient computer skills including Microsoft Office Suite: Excel, PowerPoint, Outlook, Word, and Teams. Ability to design chemical manufacturing fixtures/tooling and developing large-scale industrial manufacturing processes. Desired Qualifications. Master’s degree in chemical engineering, Chemistry, Chemical Sciences, or a related field of study. A minimum of six (6) years of experience in leading medical device and/or pharmaceutical development through various advanced engineering and analytical approaches. Ability to use and apply lean management principles to initiate, analyze, improve, and create engineering projects and quality procurement systems. Comprehensive knowledge of safe handling of chemical components, solution, and mixtures when designing large-scale industrial manufacturing processes. Statistical knowledge (Green Belt or Black Belt) in Design of Experiments (DOE) and Process Capability Cpk for process development characterization and optimization.

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