Quality Engineer - SaMD/SiMD

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 with a focus of software engineering support.
• Support and advise manufacturing quality control activities with a focus on software used in manufacturing.
• 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 Software 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 design/process controls, software testing, and risk management.
• Work with SiMD and/or SaMD.
• 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.

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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