Laboratory Technician

• Assist, coordinate and build product part or prototypes builds for engineering evaluation, and validation
• Assist, prepare, develop, and implement documentation including work instructions, standard operating procedures, technical reports, change requests and test protocols which comply with GMP and Quality requirements
• Review test methods during test method development and assists with test method validations
• Assist in creating or writing test methods as needed
• Assists in the generation and design of basic testing fixtures
• Ability to set up testing by preparing equipment and records
• Ability to perform tests by following instructions from development engineers
• collect data and record test results
• analyzing test data, organizing and presenting when it is necessary in a reportable format
• Provides process/test method training to manufacturing and QA personnel
• Perform and document equipment preventative maintenance and repairs on manufacturing equipment and systems per schedule
• Ensure equipment is operating properly
• Obtaining quotes for testing and calibration
• generate purchase orders, coordinate orders and deliveries with vendors, R&D stock checking, shipping materials/receiving materials, preparing commercial invoices
• Assist in the support of Quality, Regulatory & R&D to ensure systems are compliant with all internal and external guidelines

• Minimum of a Highschool Diploma/GED
• Associates of Science degree in a technical discipline preferred
• 0-3 years of industrial experience in R&D or process development preferably in medical device or other regulated FDA/QSR and ISO environment
• Ability to work in a team
• Ability to follow/integrate instructions (written/verbal), collect data and record results
• Task oriented
• Excellent communications skills (written/verbal)
• Technical writing proficiency
• General aptitude with testing and manufacturing equipment
• Basic troubleshooting skills, exposure to product failure, and root cause investigations
• Ability to assist in executing and/or writing validations
• Ability to operate lab equipment
• Basic computer skills (MS Windows, MS Outlook, Word, Excel and PowerPoint)
• Basic math/statistics skills
• Basic knowledge of GR&R
• Basic knowledge of standard laboratory practices
• Works well under limited supervision
• Must be a US Citizen or Green Card Holder

Experience working in a laboratory and a controlled environment (cleanroom) is a plus