Solesis · 10 hours ago
Product Development Engineering Technician
Apex, North Carolina, United States
Full-time
Onsite
Entry Level
2+ years expSolesis is a leading developer and manufacturer of customized polymer-based materials for the medical device industry. The Product Development Engineering Technician will conduct tests, build prototypes, and partner with lead engineers to streamline processes and improve product designs.
Health CareManufacturing
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, 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
Qualification
Required
High school diploma or GED equivalent
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
Ability to properly complete paperwork as required according to work instructions, standards, or other specifications
Preferred
Two (2) or more years of relevant experience
Basic understanding of GMP and working within FDA-regulated industries
Basic computer skills, including the ability to use MS Outlook and automated manufacturing and quality systems
Familiarity with an ERP system and Quality Management System
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
Company
Solesis
Solesis is an innovative provider of biomaterials solutions and services primarily focused on the MedTech and Biopharma industries.
201-500 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2021-04-15Acquired
Leadership Team
John Witkowski
President and CEO
Recent News
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