Quality Assurance Engineer

Quality Engineer About Paradromics Brain-related illness is one of the last great frontiers in medicine, not because the brain is unknowable, but because it has been inaccessible.

Paradromics is building a brain-computer interface (BCI) platform that records brain activity at the highest possible resolution :

• the individual neuron.
• AI algorithms then decode this massive amount of brain-data, enabling the seamless translation of thought into treatments.
• Our first clinical application, the Connexus® BCI, will help people who are unable to speak, due to ALS, spinal cord injuries, and stroke, to communicate independently through digital devices.
• However, the capabilities of our BCI platform go far beyond our first application.
• With the brain in direct communication with digital devices, we can leverage technology to transform how we treat conditions ranging from sensory and motor deficits to untreatable mental illness.
• 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.
• Required Education Bachelor’s degree in Engineering or a related technical discipline (or equivalent experience).
• Required Qualifications 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.
• Preferred Qualifications Familiarity with active implantable medical devices.
• Experience with electromechanical medical device manufacturing.
• Exposure to SiMD and / or SaMD.
• 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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