Manufacturing Engineer

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DDS Industrial Operations Full Time Professional Fishers, IN, US

The Manufacturing Engineer is responsible for developing, maintaining, and improving manufacturing processes across the full production lifecycle, from receipt of materials and component preparation through manufacturing, assembly, inspection, packaging, and release. The role provides hands‑on engineering support for new product introduction, established production, engineering changes, and equipment and process improvements. Working with Operations, Quality, Maintenance, Automation, Supply Chain, and Process Engineering, the Manufacturing Engineer ensures processes are safe, capable, efficient, documented, validated, and compliant with applicable medical device requirements.

Production Process Ownership and Support

• Own and support the end‑to‑end manufacturing process, including material flow, equipment setup, processing, assembly, inspection, test, packaging, and transfer of completed product to the next operation or release process.
• Maintain a thorough understanding of process inputs, outputs, critical process parameters, quality characteristics, acceptance criteria, and interactions between operations.
• Provide floor‑level engineering support to resolve production issues in volving equipment, tooling, fixtures, materials, methods, automation, documentation, and operator workflow.
• Partner with Operations and Maintenance to reduce downtime, recurring equipment failures, process interruptions, and production constraints.
• Develop and maintain process flow diagrams, value stream maps, line layouts, standard work, capacity models, and manufacturing readiness assessments.
• Support production planning and capacity decisions by evaluating equipment capability, staffing assumptions, tooling needs, bottlenecks, and demand requirements.
• Ensure manufacturing processes remain in a validated and controlled state throughout routine production.
• Monitor and report manufacturing KPIs, including quality, yield, scrap, cycle time, production rate, downtime, capacity, and fulfillment.

New Product Introduction and Cross‑Functional Support

• Support design transfer and new product introduction from manufacturing concept through validated commercial production.
• Provide design‑for‑manufacturability input and identify production risks, equipment needs, tooling requirements, inspection methods, training needs, and capacity requirements.
• Support pilot builds, production trials, ramp‑up activities, and transfer to the ultimate manufacturing site.
• Collaborate with customers and cross‑functional teams regarding process capability, production issues, deviations, engineering changes, and improvement activities.

Engineering Changes and Process Improvement

• Initiate, assess, and implement Engineering Change Orders (ECOs) affecting materials, components, tooling, equipment, software, automation, process parameters, inspection methods, and manufacturing documentation.
• Evaluate the production, quality, validation, training, inventory, supplier, and regulatory impact of proposed engineering changes before implementation.
• Develop implementation plans for changes, including document updates, risk reviews, validation or verification activities, training, material disposition, and effective‑date coordination.
• Use structured problem‑solving methods such as 5 Why, Fishbone, DMAIC, and data analysis to investigate deviations, nonconformances, equipment issues, and recurring process failures.
• Support CAPA investigations and implement sustainable corrective and…