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 be the manufacturing engineer’s responsibility to implement and requalify any changes.
- Coordinate the handoff and introduction of new manufacturing processes from the applications development team into the repetitive manufacturing, production ecosystem through use of project management principles that maximize engagement of cross functional resources.
- Embrace ownership and take pride in managing the assigned manufacturing processes from handoff through the remaining process life cycle at Resonetics. The individual will be responsible and accountable for maintaining and improving key components of process performance: safety, quality, productivity, and cost.
- Introduce and setup manufacturing capacity for polymerbased 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.
- Minimum 3 years experience in an Engineering role in a manufacturing environment.
- BS degree in mechanical or industrial discipline or equivalent experience.
- Demonstrated technical writing skills.
- Working knowledge of converting methods, material science, and Lean Six Sigma principles.
- Proficient in 3D CAD (SolidWorks), 2D CAD (AutoCAD), PC-based software for word processing, spread sheets, estimating, and project management.
- 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
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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.