Program Manager ( Medical Devices)  

Job Title : : Program Manager ( Medical Devices)

Location : Wheeling, IL or Athens, TX

Job Type : : Contract Only

Job Description : :

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)