Cantel Medical

Manufacturing Engineer, Solutions Focused Factory

US-MN-Plymouth
Job ID
2017-3470
# Positions
1
Category
Operations
Cantel ENDO

Company Overview

Cantel Medical is a leading global company dedicated to delivering innovative infection prevention products and services for patients, caregivers, and other healthcare providers which improve outcomes, enhance safety and help save lives. Our products include specialized medical device reprocessing systems for endoscopy and renal dialysis, advanced water purification equipment, sterilants, disinfectants and cleaners, sterility assurance monitoring products for hospitals and dental clinics, disposable infection control products primarily for dental and GI endoscopy markets, dialysate concentrates, hollow fiber membrane filtration and separation products. Additionally, we provide technical service for our products.  

Job Overview

Provide Manufacturing Engineering support primarily to the Solutions Operations through line support, continuous improvement, capacity improvements and new product transfers. Improve the overall efficiency of the manufacturing operation while optimizing human work factors, quality control, material flow, etc. by identifying areas for improvement through the use of statistics and root cause analysis tools. Other responsibilities include manufacturing processes development, integration of lean manufacturing concepts into the organization, and project planning.

Main Responsibilities

Line Support

  • 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.
  • Execute GMP manufacturing assessments.
  • 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.
  • Make use of appropriate quality tools, such as DOE, SPC, hypothesis testing, capability studies and PFMEA’s to measure, monitor, improve and control the manufacturing line and select processes.
  • 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.

 

Specific Duties and Responsibilities (Solutions)

  • Participate and contribute within a self-directed Value Stream Team for the Solutions focused factory.
  • Work within a team environment with all levels of the organization.
  • Create project plans and organize resources to ensure project milestones are met within expectations of timeline, quality and budget.
  • Review and approve product engineering change orders and packaging process changes, including labels specifications and packaging related content.
  • Consult with vendors in the development of packaging processes.
  • Maintain accurate and compliant documentation to meet Company, client, and regulatory expectations.
  • Justify and prepare capital expenditures for new packaging processes and equipment.
  • Support manufacturing issues, CAPA’s, SCARS and audits.
  • Develop bar codes, symbology, and labeling processes when appropriate.
  • Drive the interaction of key package, product, process and Supply Chain interfaces and incorporate them into packaging design.
  • Occasional travel to customers or suppliers as required.

Qualifications

  • BS in Engineering, preferably, Manufacturing Engineering, Industrial Engineering, or Mechanical Engineering.
  • Minimum of 5 years of Manufacturing Engineering experience, preferably within the liquid packaging industry.
  • Familiar 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
  • Controls experience is a plus
  • CAD experience is a plus

Minimum Qualifications

Cantel Medical company is an Equal Employment Opportunity/Affirmative Employer. Women, minorities, veterans, and individuals with disabilities as well as other qualified individuals are encouraged to apply. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or national origin or other protected class status.

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