Summary

This position focuses on optimizing manufacturing processes to produce medical devices safely, efficiently, and to high quality standards. The role involves heavy day-to-day engagement with manufacturing operations to ensure equipment performs at optimal levels. A key focus will be using data-driven solutions for the continuous improvement of existing and new processes as well as supporting existing products through sustaining engineering activities. Success in this role requires a balance of analytical planning and direct, hands-on implementation and troubleshooting.

Primary Responsibilities

Work independently and within project teams to establish and achieve manufacturing improvement goals.

Drive sustaining engineering activities to ensure performance and adherence to industry standards while maintaining product continuity for customers.

Collaborate and coordinate with new vendors for materials, material replacements, supply chain, and equipment needs.

Identify and address efficiency bottlenecks and process shortcomings.

Lead root cause analysis (RCA) to drive process efficiency and reduce quality defects.

Perform data analysis to support and drive decisions for current and future process improvements.

Define specifications for new and existing equipment

Assess and qualify new suppliers, conduct technical reviews of materials or machine information

Assess existing equipment to identify safety concerns and recommend necessary upgrades

Identify, secure, and implement updates to equipment to support manufacturing demand.

Lead efforts to meet ISO 13485 requirements for process implementation and validation (IQ/OQ/PQ).

Ensure manufacturing equipment runs at optimal performance to meet safety, quality, and customer demand requirements.

Ensure change management procedures are followed and changes (ECOs) are properly validated and documented per the Quality Management System (QMS).

Maintain manufacturing documentation, including component drawings and specifications, inspection plans, bills of materials (BOM), assembly/packaging drawings, SOPs, work instructions, quality plans, and other required documents.

Ensure all documentation complies with company quality system and customer requirements.

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WillowWood Global LLC

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