Lab Technician

Job Description

The primary focus of this position is to assist R&D engineers in medical device process testing and development. This includes performing tests, collecting and analyzing data, developing, optimizing, and validating processes for building a medical device, building units for engineering.

• 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. Sets up and operates manufacturing equipment.
• Process Development: Assist in new process development for new or existing medical devices and processes, supporting tooling and equipment development. Assists in conceptual input to the design of fixtures, tooling and equipment, as well as assists with recommendation, specification and procurement of capital equipment.
• 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; analyzing test data, organizing, and presenting when it is necessary in a reportable format. Assists in the execution of test protocols and procedures. Sets up test equipment for testing to protocols.
• Mentoring/Coaching: Provide process/test method training to manufacturing and QA personnel. Peer-peer coaching other technicians on R&D based tasks and responsibilities.

Required Qualifications

• A high school diploma/GED required. An associates of science degree in science, math or engineering is 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 and ability to enter data in Microsoft Project and / or Minitab for data analysis.
• Ability to assist in design. General technical awareness and ability to read and understand drawings.