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Principal Process Engineer

Company: Cantel Medical
Location: Wayzata
Posted on: November 23, 2020

Job Description:

Who we are At Cantel, preventing infection is our business. As a leading provider of infection prevention products and services in the healthcare market, we are dedicated to delivering high-quality, innovative solutions that improve outcomes and help save lives. We accomplish this mission by delivering our products through the following operating units: Medical : Endoscopy procedure disposables include single-use valves and irrigation tubing. The medical device reprocessing systems, disinfectants, detergents we manufacture and distribute are used to disinfect high-level endoscopes. Life Sciences : Water purification systems for dialysis facilities. We work with leading dialysis caregivers, delivering hemodialysis dialyzers and reprocessing systems, as well as sterilants and filtration products. Dental: Single-use, infection prevention products used primarily in the dental market (face masks, sterilization pouches, towels and bibs, tray covers, saliva ejectors, germicidal wipes, plastic cups and disinfectants). Cantel employees are inspired to improve the lives of patients, caregivers and healthcare providers. If you are looking for a company driven by an entrepreneurial spirit and have the passion to shape the future of infection prevention, we want to meet you. Join us and see why people love working here. About the role The Pr. Process Engineer will provide process engineering support to Operations through line support, continuous improvement, capacity improvements and new product transfers. Improve the overall efficiency of the manufacturing/processing operation while optimizing human work factors, quality control, material flow, etc. by identifying areas for improvement through use of statistics and root cause analysis tools. CB What you will do Line Support Provide general oversight and monitoring of machinery --- including project coordination for maintenance, upgrades, and repair when needed Lead troubleshooting of problems within the manufacturing process Identify and implement GMP (good manufacturing practices) that apply to specific production area(s). Provide training as needed to ensure that the production team understands and follows GMP. Lead/own CAPA (corrective and preventative actions) to resolve production and customer issues. Lead formal failure analysis and issue resolution activities to ensure preventative action is accomplished. Provide work direction to Product or Process technicians as required. Create written documents, test plans and reports that demonstrate technical rationale for associated decisions(s) (e.g. qualifications, risk assessments, and work instructions). Provide hands-on manufacturing equipment and process trouble shooting. Provide operations department with effective technical support to meet manufacturing quality and quantity objectives. Continuous Improvement Utilize project management skills to drive continuous improvement initiatives to optimize yield, quality, cycle time and/or ergonomics. Own and execute cost down initiatives on manufacturing lines. Initiate and lead lean transformations on manufacturing lines as well as within supporting areas. Identify process improvement opportunities and provide technical solutions via analysis and hands-on interaction with designated processes, including troubleshooting of manufacturing issues when they occur. Capacity Improvement Assess and monitor manufacturing capacity capabilities and reconcile with demand. Propose capacity improvement recommendations accordingly. Specify tooling, fixtures and equipment required to meet manufacturing capacity requirements. Coordinate efforts associated with planning, procuring, installing and qualifying tooling, fixtures and equipment. New Product Transfers Work with product development engineering to drive back lessons learned as new products are being developed. Evaluate and provide input to product development teams to help ensure the introduction of a capable and efficient operation. Create/evaluate and release process documentation for new processes. Specify tooling, fixtures and equipment required to meet manufacturing capacity requirements. Coordinate efforts associated with planning, procuring, installing and qualifying tooling, fixtures and equipment. Train operations personnel on new processes What we are looking for BS in Engineering, preferably Mechanical Engineering or Manufacturing Engineering. Minimum of 10 years of Manufacturing Engineering experience, or 8 years plus a Technical Masters Degree, preferably within the medical device manufacturing industry. CAD experience is a plus, preferably SolidWorks Familiarity with ISO 13485, FDA Design Control, CAPA, SCAR, and audit procedures. Experience in structured problem solving and use of statistical tools. Training and experience in Lean and Six Sigma, or equivalent. Experience in Design for Manufacturing, DFMEA, PFMEA, DOE, and Validations Experience in hollow fiber extrusion processes preferred Experience in chemical batch processes preferred

Keywords: Cantel Medical, Minneapolis , Principal Process Engineer, Engineering , Wayzata, Minnesota

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