Senior Quality Reliability Engineer

Senior Quality & Reliability Engineer

Precision Neuroscience is building a next-generation brain–computer interface (BCI) to heal and empower millions of people living with neurological conditions. Our first product, Layer 7, is designed to help people with severe paralysis operate digital devices using only their thoughts—opening up new possibilities for daily life. Our team brings together experts in neurosurgery, AI and machine learning, microfabrication, electrical engineering, clinical science, and more.

We combine deep technical rigor with a people-first mindset to turn breakthrough research into real-world medical solutions. As a Precision employee, you'll join one of the fastest-moving and best-capitalized companies in the emerging field of brain–computer interfaces.

We are seeking a Senior Quality & Reliability Engineer to lead production quality for the microfabrication of our Class III brain–computer interface implant at our microfabrication and device-assembly facility in Addison, Texas. In this role you will provide the technical quality oversight that keeps production compliant and capable, leading nonconformance and CAPA, process and equipment validation, and change control across the front-end MEMS microfabrication line, with extension into back-end device assembly.

You will also assess, mature, and continuously improve the site's quality processes in line with Precision's quality management system and FDA QMSR (21 CFR Part 820). The Senior Quality & Reliability Engineer reports to Sr. Quality Manager and works cross-functionally with R&D–Microfabrication, Process Engineering, and Equipment Engineering. This position will be based in our Addison, TX office.

Key Responsibilities:

• Production Quality & Reliability:
  Serve as the quality engineering owner for assigned microfabrication lines, providing floor-level technical support, dispositioning quality issues, and defining the path to resolution. Partner with Process Engineering and Equipment Engineering to contain and resolve line excursions, with a focus on maintaining production continuity. Create and maintain compliant medical device files and production records for production builds. Drive incoming, in-process, and final acceptance against documented specifications.
  
  Apply advanced statistical and data analysis techniques to identify quality & reliability risks, understand failure mechanisms for continuous improvement.
• Process & Equipment Qualification/Validation:
  Define quality/reliability requirements, design, develop and execute qualification/validation strategies (IQ/OQ/PQ) for microfabrication and device-assembly processes and equipment in partnership with Process Engineering & Equipment Engineering. Lead process risk evaluation & analysis per ISO 14971 (e.g., FMEA), translating process risk into the master validation plan (MVP), the validation/qualification activities required, and the process control plan (including testing & sampling strategy). Define and review test-method validation (TMV), including measurement-system analysis and gage R&R.
  
  Support facilities qualification (IQ/OQ) in collaboration with the Equipment and Facilities Engineering teams.
• Nonconformance, CAPA & Material Review:
  Lead the nonconformance (NCMR) and Material Review Board (MRB) process — investigation, failure analysis, disposition, and trending — with structured root-cause analysis. Lead corrective and preventive actions (CAPA): root-cause analysis, corrective action, effectiveness verification, and timely closure. Support supplier corrective action (SCAR) for material- and process-related nonconformances.
• Change Control:
  Manage the quality & reliability aspects of process and engineering change control, documenting technical quality rationale and aligning stakeholders across Process Engineering, Equipment Engineering, R&D–Microfabrication, and Regulatory. Perform change impact and reliability risk assessment, identifying and driving follow-on actions such as requalification or revalidation, including changes to process flows and recipes.
• Quality Management System & Continuous Improvement:
  Assess, mature, and continuously improve site quality…