Product Development Engineering Technician - Apex - Polyzen

    Polyzen
    Polyzen Apex

    8 hours ago

    Description
    Who we are:
    Polyzen is a leading developer and manufacturer of customized polymer-based materials, films, components, and assemblies for the medical device industry. Our range of materials and processing technologies allow us to provide optimum solutions for innovation-driven companies, ranging from entrepreneurial start-ups to major medical device manufacturers. From prototype development through full-scale production, we take pride in our quality, technical expertise, and customer service, and we strive to provide the best value throughout the product life cycle.
    1st shift Monday-Friday 8:00 am-5:00 pm
    About the role:
    The Product Development Engineering Technician performs a wide variety of activities that include conducting tests, building prototypes/samples, updating drawings, creating specifications, and identifying issues or concerns with current and new designs. This role will regularly partner with lead engineers to streamline processes through hands-on activities such as making prototypes, testing, and completing data analysis of development runs.
    What you will do:
    • Partners with the lead engineer to conduct trials, design of experiments, and testing required to design a successful manufacturing process.
    • Identifies issues or concerns with current and new designs and makes suggestions for alternative ideas of design if the situation warrants.
    • Operates production and test equipment independently.
    • Inspects product for defects and contamination according to Work Instructions (WI), Visual Inspection Criteria, SOPs, and internal specifications.
    • Assists in performing tooling (e.g., mandrels, dies) inspections and qualifications.
    • Conducts extensive data collection to support the identification of trends to increase yields through process improvement.
    • Performs tasks such as dip molding, dip coating, spray coating, solution formulation, flat die extrusion, lay flat tube extrusion, lamination, thermoforming, die cutting, RF Welding, general assembly, etc., according to WI.
    • Assist on critical pilot builds (e.g., Biocomp, Bioburden, DV builds, etc.), maintain process documentation, and perform data analysis for these builds.
    • Assist with review and creation of SOPs, Work Instructions, Batch Records, Product Specifications, Visual Standard, Process Performance Qualification, Process Operational Qualification protocol plans, and reports critical to Product development.
    • Assist with training operators on manufacturing processes that are accepted for production.
    Who you are:
    • High school diploma or GED equivalent
    • Two (2) or more years of relevant experience preferred.
    • Ability to understand and follow the requirements of applicable work instructions and/or internal specifications.
    • Ability to effectively communicate with coworkers and management. Business communication is conducted in English.
    • Ability to comprehend and follow SOPs, WIs, policies, and procedures such as safety, quality, and HR, that are written in English.
    • Possess basic mathematical skills to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
    • Ability to use measurement devices.
    • Basic understanding of GMP and working within FDA-regulated industries preferred.
    • Basic computer skills, including the ability to use MS Outlook and automated manufacturing and quality systems.
    • Ability to properly complete paperwork as required according to work instructions, standards, or other specifications.
    • Familiarity with an ERP system and Quality Management System preferred.
    Perks / Benefits:
    • Generous Paid Time Off
    • Paid Breaks
    • Annual Bonuses
    • 401k with excellent company match
    • Health Insurance with multiple plans to choose form
    • Paid Short Term and Long Term Disability
    Equal Opportunity Employer
    This employer is required to notify all applicants of their rights pursuant to federal employment laws.
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