Sr. R&D Test Technician

Shifamed•Los Gatos, CA

17h•$80,000 - $95,000

About The Position

As a Senior R&D Test Technician on the Akura team, you will be responsible for hands-on development, design, prototyping, testing, and analysis of the catheter instrument and accessories of the Akura thrombectomy system. You will be directly involved in development, testing and problem-solving in a wide range of areas including catheter assembly methods, fixture design and fabrication, performance testing, and verification & validation activities. Who we are looking for: Someone with strong self‑direction that proactively drives work forward, adapts quickly to changing priorities and evolving technical approaches. An individual who can work effectively in a fast‑moving workplace, develops solutions and adjusts workflows even when methods or processes are not yet fully defined. Someone who demonstrates strong creativity and problem-solving skills. An organized person who maintains lab notebook, workstations, equipment, inventory, and the R&D lab. A person with a continuous improvement mindset.

Requirements

A high school diploma, technical courses, or equivalent industry experience.
8+ years of experience as a technician in the medical device industry.
Proven track record in R&D catheter technologies in a rapid product development environment.
Proven track record of working in a regulated test environment, supporting design verification activities and executing testing for regulatory submissions.
Knowledge of and experience in development and fabrication of medical devices and ability to work independently as well as a team setting.
Experience working in an R&D lab and CER.

Nice To Haves

Experience using and programming Micro-Vu a plus.
Experience with catheter assembly techniques such as thermal and adhesive bonding, laser-welding and soldering a plus.
3D printing and Solidworks experience a plus.
Previous start-up experience is a plus.
Machine shop experience is a plus.

Responsibilities

Create and execute test methods.
Perform design verification testing for regulatory submissions and supporting root cause analysis of testing failures.
Document test results using good documentation practice and generate test reports.
Design, fabricate and assemble test fixtures, bench top models and jigs to aid in component assembly.
Machine shop (such as manual machining and turning).
Perform mechanical testing on tensile testers (Instron), including set up and operation, calibration, create/modify test programs and perform troubleshooting of test setup and equipment issues.
Perform dimensional and visual inspection of components and subassemblies.
Organize testing lab equipment and materials.
Establish inventory management and maintain equipment calibration and scheduling.
Assemble catheter components and electro-mechanical devices.