Manufacturing Engineer

Overview

On Site
Contract - W2

Skills

GMP
CAPA
FDA
EHS
IQ
OQ
PQ
SIP
WIP

Job Details

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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