Manufacturing Engineer

2 weeks ago

Indiana, PA, United States Fusion Life Sciences Technologies LLC Full time

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

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