Manufacturing Program Manager

3 weeks ago


Athens, United States Intellectt Inc Full time

Role: Program Manager

Location: Athens, TX - Onsite

Duration: Long Term


Essential Duties and Responsibilities

  • Project timelines preparation, lead tracker and monitor task completion.
  • Coordinate with all department leads for task completion
  • Lead new product introductions and ensure successful transition to manufacturing
  • Provide manufacturing engineering support for the development and manufacturing of new products
  • Evaluate proposed designs for manufacturability and provide DFM recommendations
  • Develop and establish robust, repeatable, and reproducible processes
  • Represent manufacturing engineering in cross-functional teams
  • Perform process validations (IQ/OQ/PQ)
  • Develop, implement, train and monitor effectiveness of engineering systems and procedures to ensure compliance to FDA, cGMP and all other applicable agency regulations

Leadership Responsibilities

  • Lead functional and cross-functional teams to achieve project goals.
  • Mentor junior manufacturing engineers in project management activities

Education and/or Experience

  • Bachelor’s Degree or higher in biomedical, mechanical, industrial or similar discipline
  • Minimum of five (5) years related experience in FDA/GMP regulated industry.
  • Proficient in SolidWorks, Minitab, Word, Excel and Project
  • Experience in product development and manufacturing methods, procedures, and cost reduction/yield improvement techniques
  • Background in medical device assembly, automation, and vision system technology
  • Experience in the application of statistical techniques such as statistical process control, design of experiments, and problem-solving techniques is required
  • Experience with design, review, execution, and approval of Installation, Operation and Process Qualification protocols and reports (IQ/OQ/PQ)

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