Product Development Engineering Technician

Solesis•Apex, NC

About The Position

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.

Requirements

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 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.

Nice To Haves

Basic understanding of GMP and working within FDA-regulated industries preferred.
Familiarity with an ERP system and Quality Management System preferred.

Responsibilities

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, s olution formulation , flat die extrusion, lay flat tube extrusion, la mination, 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.