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Manufacturing Engineer contractor

m9jdnw9bk529dob7b0nhj8hmrmhgxe030ekfy8ww115xk0jkq5bxt25ll3hbstat · 30+ days ago

Salt Lake City, UT, US

$89k+
Estimation

Full-time

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This correspondence is to inform you that 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.
MINIMUM QUALIFICATIONS:

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. Additional experience with validations related to injection molding, sterilization, and/or software would be helpful.
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
Preferred Six Sigma Green/Black Belt and/or Lean Manufacturing Tools
Strong technical, problem solving, gap assessment, Gage R&R, and statistical understanding

ESSENTIAL DUTIES AND RESPONSIBILITIES:

The following duties and responsibilities are intended to be representative of the work performed in this position and are not all-inclusive. The omission of a specific duty or responsibility will not preclude it from the role.

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.

KNOWLEDGE AND SKILLS:

Experience creating & managing calibration, PM, and spare parts systems.
Direct experience in writing and executing equipment/process validations.
Prior experience with statistical methods related to process control and validation. Experience with statistical software such as Minitab is preferred.

Contractor will be required to provide their own laptop. It is anticipated that this assignment will run through November 2020. We anticipate this role commencing ASAP and is an on-site position.

Please submit (no more than) your top 3 resumes with hourly, all-inclusive rates AND contractor availability date no later than Sunday, September 6^th to be considered for this role.

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Last updated on Sep 2, 2020

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