- 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
- Lead functional and cross-functional teams to achieve project goals.
- Mentor junior manufacturing engineers in project management activities
- 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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Manufacturing Program Manager - Athens, United States - Intellectt Inc
Description
Role: Program Manager
Location: Athens, TX - Onsite
Duration: Long Term
Essential Duties and Responsibilities
Leadership Responsibilities
Education and/or Experience
