Quality Engineer - SaMD/SiMD
Listed on 2026-02-16
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Engineering
Medical Device Industry, Biomedical Engineer
Company Overview
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, or stroke—to communicate independently through digital devices.
The BCI platform’s capabilities extend beyond this first application, allowing us to transform how we treat conditions ranging from sensory and motor deficits to untreatable mental illness.
Quality Engineer – 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. The engineer will partner closely with product development and manufacturing teams to provide creative, practical solutions, while ensuring compliance with established procedures and regulatory requirements.
- Support and advise engineers on quality compliance in product development, with a focus on software engineering support.
- Support and advise manufacturing quality‑control activities, focusing 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.
- Bachelor’s degree in Software 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 design/process controls, software testing, and risk management.
- Familiarity 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.
- 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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