R&D Technician I
Responsibilities:
- Product Builds: Assist, coordinate and build product part or prototypes builds for engineering evaluation, validation, pre-clinical and clinical studies, marketing and commercial sales. Process Development: Assist in new process development for new or existing medical devices and processes, supporting tooling and equipment development. Documentation: 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.
- Test Method Development: Review test methods during test method development and assists with test method validations.
- Testing: 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.
- Training: Provides process/test method training to manufacturing and QA personnel.
- Equipment: 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.
- Materials/Inventory: generate purchase orders, coordinate orders and deliveries with vendors, R&D stock checking, shipping materials/receiving materials, preparing commercial invoices and liaising with internal Customs specialists.
Required Qualifications:
- Minimum of a Highschool Diploma/GED. Associates of Science degree in a technical discipline preferred.
- Experience: 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 follow instructions, collect data and record results.
- Experience working in a laboratory and a controlled environment (cleanroom) is a plus.
- Ability to assist in executing validations
- Ability to operate lab equipment
- Basic computer skills (MS Windows, MS Outlook, Word, Excel and PowerPoint)
- Basic math/statistics skills.
- Minimum of a Highschool Diploma/GED. Associates of Science degree in a technical discipline preferred.
- Experience: 0-3 years of industrial experience in R&D or process development preferably in medical device or other regulated FDA/QSR and ISO environment.