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Quality Assurance Engineer

Paradromics

Austin, TXOnsitePosted 2 days ago
Full TimeMid LevelQuality (QA / QC)Medical Device
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Summary

We are seeking a Quality Engineer to join our Quality team in Austin, Texas. Reporting to the Quality Engineering Manager, this role will be central to improving the efficiency and effectiveness of our quality system while supporting the rapid development of novel neurotechnology products. This individual will partner closely with engineers across product development and manufacturing to provide creative, practical solutions, while ensuring compliance with established procedures and regulatory requirements.

Job description

The Role

We are seeking a Quality Engineer to join our Quality team in Austin, Texas. Reporting to the Quality Engineering Manager, this role will be central to improving the efficiency and effectiveness of our quality system while supporting the rapid development of novel neurotechnology products. This individual will partner closely with engineers across product development and manufacturing to provide creative, practical solutions, while ensuring compliance with established procedures and regulatory requirements.

Responsibilities

  • Support and advise engineers on quality compliance in product development.
  • Support and advise manufacturing quality control activities.
  • Review and update documentation to support product development and manufacturing.
  • Evaluate product and process risks and conduct risk mitigation activities.
  • Support compliance activities across the organization.

Requirements

  • Bachelor's degree in Engineering or a related technical discipline (or equivalent experience)
  • 3+ years' experience, at least 1 year of medical device experience
  • Experience in medical device development, particularly related to risk management and design/process controls
  • Creative problem-solving approach with the ability to generate practical solutions to complex issues
  • Strong attention to detail and excellent writing/documentation skills

Company overview

Paradromics is a pioneering medical device company specializing in the development of high-bandwidth brain-computer interfaces (BCIs) for therapeutic applications. Founded with the mission to restore communication and mobility for people with severe neurological conditions, the company focuses on creating advanced neural interface systems that can translate brain signals into digital commands with unprecedented precision and speed. Paradromics' core technology platform utilizes dense microelectrode arrays capable of recording from thousands of individual neurons simultaneously, enabling high-resolution neural data acquisition. The company's flagship product, the Connexus Direct Data Interface, is designed to help individuals with paralysis, speech impairments, and other neurological disorders regain functional capabilities. With a strong emphasis on clinical translation and regulatory pathways, Paradromics collaborates with leading neuroscientists and medical institutions to advance the field of neurotechnology. The company has attracted significant venture capital funding and is recognized as a leader in the emerging brain-computer interface industry, working toward FDA approval for its innovative medical devices.

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