Sr. R&D Test Technician
Los Gatos, CA - USA
Job Summary
Akura Medical a Shifamed Portfolio Company is focused on a differentiated approach delivering an effective solution to address the major challenges of venous thromboembolism (VTE). Akura recently announced the first-in-human use of its mechanical thrombectomy platform. Each year VTE affects as many as 900000 Americans resulting in about 100000 premature deaths. To learn more about Akura Medical please visit .
ABOUT SHIFAMED
Founded in 2009 by serial entrepreneur Amr Salahieh Shifamed LLC is a privately held medical device innovation hub focused on the development of novel medical products to address clinical needs in the rapidly evolving fields of cardiology and ophthalmology.
Description:
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 selfdirection that proactively drives work forward adapts quickly to changing priorities and evolving technical approaches. An individual who can work effectively in a fastmoving 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.
Responsibilities Skills & Hands-On Experience:
- 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.
Education & Work Experience:
- 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.
- 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.
Our salary ranges are calculated by role level and location. Please note that your position within that range will be determined by your job-related knowledge location skills experience relevant education and training/certifications. The base salary range for this temporary position is between $80000 to $95000.
NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to
NOTICE TO CANDIDATES: Please be aware that Shifamed and its portfolio companies do not conduct interviews or extend offers through mobile web chat applications. Please report any such occurrences to
Required Experience:
Senior IC