Job Description - Manufacturing Engineer II in West Valley
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Manufacturing Engineer II

Ref: US_EN_6_971649_1479310

Posted on 06 January 2023

Modis Engineering is currently recruiting for a Contract Manufacturing Engineer II in West Valley, Utah

To be considered for this position you must have experience in validations such as: manufacturing equipment, manufacturing processes, Test Method validation, stability or aging, required

 

Responsibilities for the Manufacturing Engineer II job include but are not limited to the following

Essential Duties and Responsibilities:

  • Generation and execution of validation plans, validation protocols (IQ/OQ/PQ), and completion reports, with a major focus on Test Method Validation and EUMDR Validation Remediation of medical devices.
  • Provide statistical analysis of the date to support the reports.
  • Troubleshooting equipment/processes that do not perform as intended during validation runs.
  • Recommend process/quality improvements as part of validation runs.
  • Evaluate, investigate, and document non-conformances incidents and/or protocol deviations.
  • Complete assigned Non-Conformance and CAPA investigations and prepare investigation reports.
  • Develops and maintains an effective cross-functional working relationship with plant and corporate Manufacturing, Engineering, Regulatory, and Quality Assurance personnel.
  • Work on project teams with other internal departments, external vendors, and customers as required.
  • Assure that existing processes and assigned activities fully comply with regulatory and/or international agencies, such as FDA, ISO, OSHA, EPA, among others.
  • Participate in the compilation and review of technical documentation for both domestic and international regulatory submissions. Participate in external audits such as: FDA, Notified Body (BSI) and Corporate, among others.
  • Performs other related duties as necessary.
  • Education / Experience:

  • BS in Engineering, preferably Mechanical, Manufacturing, Industrial, Electrical, Chemical, or Biomedical (Professional Engineer License.) or sciences related field.
  • Lean/Six Sigma Green or Black Belt Certification is a plus.
  • Experience in validations such as: manufacturing equipment, manufacturing processes, Test Method validation, stability or aging, required.
  • Minimum of 4-6 years of experience in the medical device and/or pharmaceutical manufacturing environment
  • Skills and Abilities:

  • Knowledge of FDA, OSHA, EPA, and GMP's and ISO requirements.
  • Knowledge in Organizational Excellence and Lean/Six Sigma.
  • Strong Project Management skills.
  • Ability to lead teams through complex projects and provide departmental technical leadership.
  • Must have excellent communication skills and a strong track record of working cross-functionally.
  • Must have demonstrated ability to think strategically.
  • Able to develop technical documentation such as: Change Controls, Validation Plans, Validation Protocols, Technical / investigation reports, SOP, and others.
  • Teamwork oriented and self-starter.
  • • This role is restricted to U.S. persons (i.e., U.S. citizens, permanent residents, and other protected individuals under the Immigration and Naturalization Act, 8 U.S.C. 1324b(a)(3)).

    Equal Opportunity Employer/Veterans/Disabled

    To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.modis.com/en-us/candidate-privacy

    The Company will consider qualified applicants with arrest and conviction records

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