Overview

The principal responsibility of this position is to develop and maintain manufacturing processes to meet acceptable standards of manufacturability and compliance to the Resonetics Quality System.  Manufacturing processes shall include but not limited to photo chemical etching/machining (coat/expose/develop/etch/clean), shear, ovens, laser marking, automation, inspection and/or measurement.

This position will concentrate on establishing and improving efficiencies in the manufacturing of medical devices. Additional areas of focus may include but are not limited to setup reduction, statistical process control/variation reduction, work cell design/optimization, operator training/work instructions and tool/machine design selection or improvements. Other daily responsibilities will include procedure generation, participation in production readiness/product validation activities for customers, developing and deploying continuous improvement plans for production products and procedure generation. An important aspect of this position is the hands-on nature of this role. As improvements are identified, it will very likely be the responsibility of this individual to implement and re-qualify changes.

Responsibilities

• Take ownership of specific manufacturing processes as they pass through the final stages of production readiness and process validation to ensure that quality awareness and product integrity are maintained.
• Lead or contribute to project teams responsible for implementing process improvements and new technologies.
• Determine job cost baselines and initiate cost reduction activities.
• Review existing process procedures for compliance to the designed process intent. Modify procedures as necessary and obtain approval from the originating process engineer.
• Periodic customer liaison for quality or continuation engineering related issues. May assume project manager role for specific customer applications.
• Provide technical support for process validation activities to ensure a smooth transition into the production environment.
• Perform Design of Experiments (DOE’s) where process assessment for optimization is required.
• Develop process documentation and training where applicable (manufacturing process, tool/machine setup, preventive maintenance etc.).
• Analyze and evaluate existing processes, manufacturing practices and systems to identify inefficiencies, bottlenecks, and areas for improvement.
• Develop or assist in design, costing, training for continuous improvement activities.
• Weekly/monthly reporting of activities and chosen performance metrics.

Qualifications

• Minimum 3 years’ experience in an engineering role or 5 years’ experience in a technician role in a manufacturing environment.
• BS degree in chemical engineering or material science preferred (mechanical engineer or chemistry will also be considered) or 2-year technical degree with additional manufacturing experience.
• Strong oral communication skill and demonstrated technical writing skills: able to write detailed reports, comprehensive manufacturing procedures and assist Quality Engineering with validation protocols

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