Manufacturing Engineer contractor

Full-time - Mid Level

Salt Lake City, UT

Professional, Scientific, and Technical Services

About the position

Clinical Innovations, a state-of-the-art disposable medical devices developer/manufacturer, is looking for a full-time Manufacturing Engineer contractor. The Manufacturing Engineer contractor will work under the direction of the Sr. Manufacturing Manager or designate to address gaps and issues related to manufacturing and production. Some of the specific areas of focus will be remediation of the Calibration System, PM System, Spare Parts System, CAPAs. In addition, this position will support production, execute assigned tasks/projects, and identify opportunities for continuous improvement.

Responsibilities

• Assists remediation of the Calibration, PM, and other manufacturing and control plan systems.
• Helps with continuous process improvement and problem resolution.
• Performs product/process analysis for cost reduction, quality improvement, and improved efficiency.
• Supports Lean, Six Sigma practices.
• Create, document, develop, and implement procedures required to assemble, test, process, and manufacture the products of the company.
• Assures product and process quality.
• Perform complaint and return analyses for assigned product lines/processes.
• Update processes and procedures related to calibration, PM, spare parts, etc. to ensure that these systems meet GMP, quality/regulatory requirements, and are sustainable to ensure ongoing support of our manufacturing system.
• Writes / approves validation protocols (IQ, OQ, and PQ).
• Generates ECN's compliant with our change control procedures.
• Executes and supports validation activities as the site.
• Other duties as assigned.

Requirements

• 4 year Engineering Degree
• 5 plus years relevant experience with 3 or more years of experience in drug or medical device industry
• Extensive experience in a manufacturing environment working with operators and production equipment/processes.
• Experience creating preventative maintenance (PM) systems, calibration plans, spare part plans, SOPs, complaint investigations, etc.
• Experience with equipment, process, and test method validations in a manufacturing environment.
• Experience with addressing quality/regulatory issues such as non-conformance reports (from production, calibration, etc.), CAPAs, etc.
• Strong project management skills
• Strong attention to detail

Nice-to-haves

• Preferred Six Sigma Green/Black Belt and/or Lean Manufacturing Tools
• Strong technical, problem solving, gap assessment, Gage R&R, and statistical understanding
• Experience with statistical software such as Minitab is preferred.

Benefits

• Contractor will be required to provide their own laptop.
• On-site position.