Manufacturing Engineer - Katalyst Healthcares & Life Sciences
Wheeling, IL 60004
About the Job
Responsibilities:
- 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
- Perform root cause analysis of product/process issues and implement short and long-term corrective actions to
- 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
- Confer with vendors to determine product specifications and arrange for purchase of equipment, materials or
- Estimate production times, staffing requirements, and related costs to provide information for management
- Confer with management, engineering, and other staff regarding production capabilities, production schedules,
- Develop, implement, train and monitor effectiveness of engineering systems and procedures to ensure
- Lead functional and cross-functional teams to achieve project goals.Mentor junior manufacturing engineers in project management activities
Requirements:
- 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
- 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,
- Experience with design, review, execution, and approval of Installation, Operation and Process Qualification
Source : Katalyst Healthcares & Life Sciences