Manufacturing Engineer - Arlington Heights, United States - Katalyst HealthCares & Life Sciences

Katalyst HealthCares & Life Sciences Arlington Heights, United States

1 week ago

Description

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

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