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 may include but not limited to forming, shearing, laser and resistance welding, laser marking, wire cutting and stripping, adhesive/paste dispense, curing, electrical testing, machining (centerless grinding, Wire EDM, etc.), cleaning, automated 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.
- 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.
- 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.).
- Develop or assist in design, costing, training for continuous improvement activities.
- Weekly/monthly reporting of activities and chosen performance attributes.
- Minimum 3 years’ experience in an engineering role or 5 years’ experience in a technician role in a manufacturing environment.
- BS degree in engineering (mechanical, industrial, manufacturing, chemical) or equivalent 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.
- Prior experience with some of the following manufacturing processes: forming, shearing, laser and resistance welding, laser marking, wire cutting and stripping, adhesive/paste dispense, curing, electrical testing, machining (centerless grinding, Wire EDM, etc.), cleaning, automated inspection and/or measurement.
- Prior experience working in an engineering role within the medical device industry (ISO 13485) or other regulated industry.
- Working knowledge of statistical software and/or Minitab.
- Knowledge of SPC or other process capability analysis for use in the determination of production readiness.
- Project management and leadership skills.
- Lean training, certification and/or experience.
If qualified, apply now. Job title and job location must be included in the application.
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Limitations and Disclaimer: The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position. Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.