Job Description - Manufacturing Engineer II in West Valley
Return to jobs

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

    The Company will consider qualified applicants with arrest and conviction records

    Find your local office.

    Modis has over 100 offices in the United States, Canada and Europe. With both industry and location-specific expertise, our people know their area and their labor market and can find the right position for you.