Manufacturing Engineer
Job Title: Manufacturing Engineer Client: Medical Device Manufacturing Company Location: Warsaw, IN 46582 Duration: 2 Years (Possible Extension) Shift: 1st Shift Job Summary Provides hands-on shop floor engineering support across machining, metal finishing, and assembly. Focuses on process optimization, compliance, and continuous improvement in a regulated medical device environment. Key Responsibilities Support and improve manufacturing processes for assigned product lines Maintain and update Manufacturing Process Planning documentation Drive process improvements to enhance quality, cost, and delivery Execute change control activities and CAPA processes Support validation and qualification studies Collaborate with suppliers and internal teams to resolve production issues Ensure compliance with regulatory and quality standards Core Duties Develop and optimize manufacturing layouts, workflows, and procedures Interpret engineering drawings and translate into manufacturing processes Manage change requests, approvals, and implementation Maintain BOMs, routings, work centers, and ERP master data Analyze equipment performance and initiate corrective actions Support Lean/Six Sigma initiatives for process improvement Coordinate production data updates and documentation Technical Requirements ERP systems experience (SAP preferred) Knowledge of medical device regulations (ISO 13485, 21 CFR Part 820, etc.) Experience with change control and CAPA systems Understanding of statistical process control and validation methods Qualifications Bachelor's degree in Engineering 2 years experience OR Master's degree with relevant exposure Key Skills Strong analytical and problem-solving ability Effective communication and cross-functional collaboration Ability to work in fast-paced, regulated environments Continuous improvement mindset (Lean / Six Sigma exposure) Additional Information Individual contributor role with moderate project ownership Involves coordination across engineering, quality, and supply chain teams Opportunity to mentor junior team members #ZR SAP, Medical Device