Laboratory Technician

Primary Focus

This position focuses on assisting R&D engineers in medical device process testing and development. Key responsibilities include:

• Product Builds: Assist, coordinate, track and build product part or prototype 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 formal test protocols and reports 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; analyze test data, organize and present when necessary in a reportable format.
• Equipment: Perform and document equipment preventative maintenance and repairs on manufacturing equipment and systems per schedule. Ensure equipment is operating properly. Obtain 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 liaise with internal Customs specialists.
• Mentoring/Coaching: Peer-peer coaching other technicians on R&D based tasks and responsibilities.

Requirements

• Onsite, in the lab 3 Must Haves On The Resume
• 2 to 4 Years prior experience as a technician in a lab setting (Medical preferred)
• Understanding of good documentation practices (GDP)
• Proficient in entering/analyzing data in Excel (Minitab a plus)

Qualifications

• High School Diploma/GED required; Associates of Science degree in science, math or engineering preferred.
• Experience in R&D or related process development experience; medical device or other regulated environment highly preferred.
• Experience working in a development testing lab with knowledge of good documentation practices.
• Ability to assist in executing testing protocols.
• Ability to assist in design.
• General technical awareness and ability to read and understand drawings.