Staff Engineer, Chemical Manufacturing

Job Overview

Responsible for leading 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 specifications while considering safety, efficiency, cost, and environmental 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.

• Lead and manage improvement, development, and 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 product, equipment, and processes.
• Lead collaboration with other departments to solve manufacturing production issues.
• Manage equipment maintenance program and monitor sustainment health metrics.
• Manage builds for new product development in prototype and pilot production settings, including training of operators and coordination with production planning.
• 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.
• Manage process validation and product transfer activities across different manufacturing facilities.
• Investigate and test product processes and identify and review system deficiencies (e.g., NCRs, DCs, EO’s).
• Identify and execute improvements, issues, or any process requirement with minimum supervision.
• Comply with applicable laws and regulations, adhere to Quality Management System processes and requirements, and demonstrate ethics and integrity in all matters and at all levels throughout the organization.
• Perform additional duties as assigned.

$111,000 – $138,000. Financial compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs, and market demand.

• Bachelor of Science in Chemical Engineering, Chemistry, Chemical Sciences, or a related field of study.
• At least 6 years of relevant chemical, pharmaceutical, and/or medical device manufacturing experience.
• Strong written and verbal communication skills.
• Proficient computer skills including Microsoft Office Suite (Excel, PowerPoint, Outlook, Word, Teams).
• Ability to use and apply lean management principles to initiate, analyze, improve, and create engineering projects and quality procurement systems.
• Ability to prioritize and meet deadlines in a timely manner.
• Comprehensive knowledge of safe handling of chemical components, solutions, and mixtures when developing large-scale industrial manufacturing processes.
• Master’s degree in Chemical Engineering, Chemistry, Chemical Sciences, or a related field of study.
• At least 8 years of experience in leading medical device and/or pharmaceutical development through various advanced engineering and analytical approaches.
• Expertise in Design of Experiments (DOE) for road mapping full chemical characterization and processes during development and optimization stages.
• Statistical knowledge (Green Belt or Black Belt) in DOE and Process Capability (Cpk) for process development characterization and optimization.