R&D Technician

Job Summary

The Technician II assists R & D engineers and/or teams in the development, building, testing, and analysis of products, materials, and processes. This position will report directly to R&D Engineer or Manager. Assembly efforts may include, but are not limited to, final medical devices, finished assemblies, and sub-assemblies, working at bench, inside or outside of the clean room. The role will support training of assemblers, technicians, and new engineers in procedures, techniques, and testing, during individual personnel onboarding, V&V efforts, process qualification efforts, or the transfer of new products into manufacturing. Will support the manufacturing procedures and provide input into the design and build simple fixtures for use in assembly or testing of materials and assemblies.

Job Details/Responsibilities

• Assemble prototype products per design specifications, drawing and/or engineering direction.
• Assemble parts by using small instruments with or without a microscope, and through the operations of automated/semi-automated equipment.
• Troubleshoot and suggest creative solutions to design and process issues.
• Assist design and development projects for new products, product/process improvements, and enhancements to testing, tooling, and fixtures.
• Fabricates complex prototypes and process tools and develops and builds fixtures with minimal supervision.
• Support the fabrication of fixtures and other devices using small equipment and handheld tools.
• Support training of all levels of assemblers, technicians, and new engineers in procedures and common practices.

Knowledge, Skills and Abilities (KSA)

• Independently works on project tasks and assignments to support timely completion of project activities under general supervision.
• Familiar with general laboratory practices such as handling of chemicals, the use of machine shop tools.
• Knowledge of measurement methods and mechanical test methods (tensile, compression, fatigue, etc.).
• Able to keep detailed engineering notebook notes and experiment documentation.
• Broad knowledge of medical device assembly processes and goods manufacturing practices (GMP).
• Must be able to support the design of, and build/assemble simple fixtures using sketches, CAD, etc.
• Working knowledge of the FDA (US) and PMDA(Japan) Quality System Regulations, and ISO 13485

Qualifications/ Background Experiences

• A high school diploma or GED is required
• Minimum of 3 years direct experience as a R&D technician, or 5 years as a manufacturing operator/assembler
• An associate degree or some college classes may be considered in place of direct experience