Quality EngineerThe RoleWe 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 EducationBachelor'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.
