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Program Manager ( Medical Devices)

Program Manager ( Medical Devices)

Emonics LLCIllinois, United States
30+ days ago
Job description

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)