This position has two primary areas of focus:
Introducing and establishing new life science manufacturing technology to Resonetics such as tipping, molding, UV welding and associated manufacturing technologies utilized for balloon and catheter assembly, plus providing a technical liaison between the Applications Engineering organization and Production.
This position will concentrate primarily on establishing and improving efficiencies in the manufacturing of medical devices. Additional areas of focus may include but are not limited to: setup reduction, operator training, statistical process control, tool design or selection, and performance metrics. Other daily responsibilities will include; procedure generation, participation in all production readiness activities for new clients and designing continuous improvement plans for current production jobs. 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 actually implement and re-qualify any changes.
• Introduce and set-up manufacturing capacity for polymer-based medical device manufacturing
• Review existing process procedures for compliance to the designed process intent. Modify procedures as necessary and obtain approval from originating process engineer.
• Take ownership of specific manufacturing processes as they pass through the final stages of production readiness to insure that quality awareness and product integrity are maintained.
• Provide technical support for all process validation activities to insure a smooth transition into the production environment.
• Determine job cost baselines and initiate cost reduction activities.
• Provide assistance in job setup and process training for operators.
• Weekly/monthly reporting of activities and chosen performance attributes.
• Periodic Customer liaison for quality or continuation engineering related issues. May assume project manager role for specific customer applications.
• 6 -10 years experience in an Engineering role in a manufacturing environment.
• BS degree in mechanical or industrial discipline or equivalent experience.
• Demonstrated technical writing skills.
• Familiarity with QSR or ISO 13485 is required.
• Prior experience working in an engineering role within the medical device industry
• Experience or knowledge in Laser and Optical Theory
• Experience or knowledge in Laser Processing of Polymer based materials