Test Engineer

1 week ago

Austin, Texas, United States Paradromics Inc. Full time
About Paradromics

We are a pioneering company that is revolutionizing the field of brain-computer interfaces (BCIs) by developing a direct data interface with the brain. Our mission is to provide innovative technology solutions to unmet medical challenges. Our flagship product, the Connexus Direct Data Interface (DDI), is a game-changer in the industry, collecting neural signals at an unprecedented high data-rate and designed for long-term daily use.

The Role

We are seeking a highly skilled Test Engineer to join our team. As a Test Engineer, you will be responsible for planning and executing internal testing activities as prescribed through Research and Development (R&D) needs and the Design Control Process efforts. This includes basic characterization testing and broader Verification/Validation (V&V) testing with a primary focus on implantable active electronic devices and neural implant testing.

Responsibilities

  • Lead internal testing execution efforts, including characterization testing and V&V testing, to ensure the quality and safety of our medical devices.
  • Develop and implement test protocols and test reports to document testing activities and results.
  • Collaborate with cross-functional teams, including R&D, Manufacturing, and Quality, to ensure seamless testing and validation processes.
  • Assist in the development of US FDA submissions, including Q-Subs, IDE, and PMA, specifically regarding testing and test results.
  • Contribute to the creation of SOPs, work instructions, and other quality system elements to ensure efficient management of testing activities.

Requirements

  • Master's degree in an Engineering, Science, or technical field.
  • 3+ years' experience in neural implants, brain-computer interfaces, or medical device development and testing.
  • Experience with medical device quality standards and regulations, including Title 21 CFR Part 820 and ISO 13485.
  • Strong analytical and problem-solving skills, with the ability to develop creative solutions to complex problems.
  • Excellent communication and collaboration skills, with the ability to work effectively with cross-functional teams.

Preferred Qualifications

  • Experience working directly in the brain-computer interface space or deep brain stimulation.
  • Advanced knowledge of testing methods, including accelerated aging of intracortical or peripheral arrays.
  • Experience with microfabrication processes and detailed knowledge of insulator deposition on neural implants.

Paradromics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin.

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