Fusion Life Sciences Technologies LLC
Manufacturing Engineer
Fusion Life Sciences Technologies LLC, Phoenix, Arizona, United States
Job Title: Manufacturing Engineer Location: Warsaw, IN Role Summary: Lead manufacturing engineering activities across multiple orthopedic implant and instrument value streams, providing technical leadership, operational support, and continuous improvement in a regulated manufacturing environment. Key Responsibilities: · Lead and mentor a team of 4 Manufacturing Engineers, providing technical guidance and daily support. · Serve as Subject Matter Expert (SME) for injection molding and knee machining operations, supporting issue resolution and process stability. · Support manufacturing operations across 7 value streams, including knee machining, hip cup additive manufacturing, polymer injection molding. · Manage and resolve nonconformances related to machining, finishing, packaging, and cleanroom operations. · Author and execute equipment and process validations (EQ, OQ, PQ) in compliance with quality and regulatory requirements. · Support strategic initiatives focused on cost reduction, work-in-process (WIP) reduction, and operational efficiency. · Drive backorder reduction and support resolution of production constraints. · Lead and support issue evaluations to ensure timely root cause analysis and closure. · Update and improve work instructions to enhance operator efficiency, engagement, and compliance. · Identify and close EHS and operational improvement actions, including “Good Saves” and safety observations. · Maintain and update master BOMs and routers within JD Edwards (JDE). · Execute plant layout and floor space optimization initiatives to improve manufacturing efficiency. Skills & Competencies Highlighted · Manufacturing Engineering Leadership · Orthopedic Implants & Surgical Instruments · Injection Molding & Machining SME · GMP / Regulated Manufacturing · Validation (EQ/OQ/PQ) · Nonconformance & Issue Management · Continuous Improvement & Lean Manufacturing · ERP (JDE), BOMs & Routings · EHS & Operational Excellence