RT
Product Design Engineer
Accepting applicationsRetractable Technologies, Inc · Little Elm, TX
Full-Time Associate
Posted
3d ago
Category
Verification
Experience
Associate
Country
United States
Develops and implements quality control systems, inspects and tests products, and analyzes data to ensure products meet safety and quality standards such as ISO13485, Medical Device Regulation 2017/745 (EU MDR), 93/42/EEC, MSDAP and the US Code of Federal Regulations.
ESSENTIAL DUTIES AND RESPONSIBILITIES
The essential duties and responsibilities include the following. Other duties may be assigned.
Plans, designs, and develops new products and components.
Ability to speak, read and write both English and Mandarin.
Coordinates multiple projects.
Conceives, plans, and conducts research in problem areas of considerable scope and complexity.
Contributes inventions, new designs or techniques of material significance in the solution of problems.
Improves the functionality and reliability of current products and components. Designs and develops related modification, packaging, testing, and improvement recommendations.
Develops design verification procedures and test methods using basic engineering principles.
Ability to make new drawings and change drawings using Autodesk Inventor and Auto CAD.
Handles design control documentation of product and components in R&D according to departmental procedures, ISO 9001, ISO 13485, and FDA 21 CFR Part 820.
Reviews patent application claims of new designs.
Create and modify product package labeling using Adobe Illustrator.
Create UPC and QR codes to be used on packaging artworks.
Obtain artwork approvals from Product Development, Regulatory, and Clinical Affairs.
Review and correct vendor artwork proofs.
Maintain good records on artwork revisions.
Submit new translation requests and maintain translation glossary.
Assist in creating label templates using Loftware and Microsoft Office.
Identifies deadlines and implements methods to comply with responsibilities in a timely fashion.
Ability to get along with others, follows directions, and works well under stressful conditions.
Responsible for following company policies and procedures, including but not limited to, Quality System Regulations, safety/housekeeping, and Quality Management System.
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ESSENTIAL DUTIES AND RESPONSIBILITIES
The essential duties and responsibilities include the following. Other duties may be assigned.
Plans, designs, and develops new products and components.
Ability to speak, read and write both English and Mandarin.
Coordinates multiple projects.
Conceives, plans, and conducts research in problem areas of considerable scope and complexity.
Contributes inventions, new designs or techniques of material significance in the solution of problems.
Improves the functionality and reliability of current products and components. Designs and develops related modification, packaging, testing, and improvement recommendations.
Develops design verification procedures and test methods using basic engineering principles.
Ability to make new drawings and change drawings using Autodesk Inventor and Auto CAD.
Handles design control documentation of product and components in R&D according to departmental procedures, ISO 9001, ISO 13485, and FDA 21 CFR Part 820.
Reviews patent application claims of new designs.
Create and modify product package labeling using Adobe Illustrator.
Create UPC and QR codes to be used on packaging artworks.
Obtain artwork approvals from Product Development, Regulatory, and Clinical Affairs.
Review and correct vendor artwork proofs.
Maintain good records on artwork revisions.
Submit new translation requests and maintain translation glossary.
Assist in creating label templates using Loftware and Microsoft Office.
Identifies deadlines and implements methods to comply with responsibilities in a timely fashion.
Ability to get along with others, follows directions, and works well under stressful conditions.
Responsible for following company policies and procedures, including but not limited to, Quality System Regulations, safety/housekeeping, and Quality Management System.
Show more Show less