Intellectt INC
Location
Athens, GA | United States
Job description
Job Title: Program Manager
Location: Athens, TX
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)
Monitor, evaluate and report project progress and results
Prepare technical reports, analysis, recommendations, and presentations reflecting the status and results of
projects in progress on a regular basis
Perform root cause analysis of product/process issues and implement short and long-term corrective actions to
improve product quality
Prepare technical and validation protocols, written reports, documentation, and engineering change notifications
Provides technical supplier management support as related to product development and introduction
Analyze and plan work force utilization, space requirements, and workflow and designs layout of equipment and
workspace for maximum efficiency.
Confer with vendors to determine product specifications and arrange for purchase of equipment, materials or
parts and evaluate products according to specifications and quality standards
Estimate production times, staffing requirements, and related costs to provide information for management
decisions.
Confer with management, engineering, and other staff regarding production capabilities, production schedules,
and other considerations to facilitate production processes
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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