Precision Neuroscience is building a next-generation brain-computer interface for people living with neurological conditions. Its first product, Layer 7, is designed to help people with severe paralysis operate digital devices using only their thoughts. Founded in 2021, the company has raised more than $180 million and has initiated human trials with hospitals across the country.

About the role

This role leads production quality for the microfabrication of Precision's Class III brain-computer interface implant at the microfabrication and device-assembly facility in Addison, Texas. It provides technical quality oversight keeping production compliant and capable, leading nonconformance and CAPA, process and equipment validation, and change control across the front-end MEMS line, extending into back-end device assembly.

The role reports to the Senior Quality Manager and works cross-functionally with R&D Microfabrication, Process Engineering and Equipment Engineering.

Production quality and reliability

• Act as quality engineering owner for assigned microfabrication lines, providing floor-level technical support and dispositioning quality issues.
• Partner with Process and Equipment Engineering to contain and resolve line excursions while maintaining production continuity.
• Drive incoming, in-process and final acceptance against documented specifications.
• Apply statistical and data analysis techniques to identify quality and reliability risks.

Qualification and validation

• Design and execute qualification and validation strategies (IQ/OQ/PQ) for microfabrication and device-assembly processes and equipment.
• Lead process risk evaluation per ISO 14971, translating risk into the master validation plan and process control plan.
• Define and review test-method validation including measurement-system analysis and gage R&R.

Nonconformance, CAPA and change control

• Lead the NCMR and Material Review Board process, covering investigation, failure analysis, disposition and trending.
• Lead corrective and preventive actions through root-cause analysis, effectiveness verification and timely closure.
• Manage quality and reliability aspects of process and engineering change control, including impact and risk assessment.

What they are looking for

• A BS in engineering with 5 to 10 years of quality, reliability or process engineering experience in regulated or high-reliability manufacturing, or an MS with 3 to 8 years.
• Hands-on experience in a microfabrication, semiconductor fab or comparable cleanroom manufacturing environment.
• Equipment and process qualification and validation experience, plus statistical methods including SPC, Cpk/Ppk, gage R&R and DOE.
• Working knowledge of ISO 13485 and FDA QMSR, or an equivalent regulated-industry quality system.
• Preferred: Class III or active implantable device manufacturing, MEMS quality experience, and Computer System Validation per GAMP 5.

This position is based in the Addison, TX office.