Senior Quality Engineer

Senior Quality Engineer

Job type:
Full Time
· Department:
Quality
· Work type:
On‑Site
· USD ,000 / year

Addison, Texas, United States

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. Since our founding in 2021, we have raised more than $180 million, advanced our technology through validation, and initiated human trials with leading hospitals across the country.

• Build for human impact, measuring progress by the lives our work can change.
• Do no harm, holding ourselves to the highest standards of safety, integrity, and responsibility.
• Innovate with urgency, because the stakes are high and our users can’t wait.
• Bring sharp minds, open ears, pairing expertise with curiosity, humility, and respect.
• Lead the way, taking ownership of our work and helping to shape the future of our field.

We are seeking a Senior Quality 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 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. We are unable to consider remote workers or individuals who are not currently based in the US and are not legally authorized to work in the US.

• Production & Operations Quality
  • 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 manufacturing line issues, 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.
• Process & Equipment Validation
  • Define quality requirements, review and approve equipment qualification (IQ/OQ) and process validation (MVP, OQ/PQ) for microfabrication and device‑assembly processes and equipment, executed in partnership with Equipment Engineering and Process Engineering.
  • Lead process risk analysis per ISO 14971, translating risk into the master validation plan (MVP), the validation activities required, and the process control plan (including testing 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, 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…