Senior Quality Engineer

ABOUT PRECISION NEUROSCIENCE 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. Our Values: We build for human impact , measuring progress by the lives our work can change. We do no harm , holding ourselves to the highest standards of safety, integrity, and responsibility. We innovate with urgency , because the stakes are high and our users can’t wait. We bring sharp minds, open ears , pairing expertise with curiosity, humility, and respect. And we 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. Key Responsibilities 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 (SCAR) for material‑ and process‑related nonconformances. Change Control Manage the quality 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 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 processes in line with Precision’s quality management system and FDA QMSR (21 CFR Part 820). Own and advance the site validation program for production equipment, processes, and software (including Computer System Validation per GAMP 5 / 21 CFR Part 11). Author QMS documents such as SOPs, work instructions, and forms/templates. Design Transfer & New Product Introduction Partner with R&D‑Microfabrication and Process Engineering on design transfer and production release for new and transferring programs, including wafer‑level test and inspection and quality planning for new product introduction (NPI). Contribute to design risk management (ISO 14971, design FMEA) for transferring programs. Skills, Knowledge and Expertise Required Education + experience: BS in Engineering (Mechanical, Biomedical, Materials, Chemical, Industrial, or related) + 5–10 years of quality engineering experience in regulated or high‑reliability manufacturing; or MS in Engineering + 3–8 years of relevant experience. Hands‑on experience in a microfabrication, semiconductor fab, or comparable cleanroom manufacturing environment. Demonstrated technical depth, including: Equipment and process qualification and validation (IQ/OQ/PQ or equivalent), authoring and execution. Process and engineering change control, including change impact and risk assessment driving requalification or revalidation. Statistical methods – SPC, sampling plans, process capability (Cpk), gage R&R, and design of experiments (DOE) – sufficient to support validation and partner with process engineering on yield and variation reduction. Nonconformance (NCMR/MRB) and CAPA ownership with structured root‑cause analysis. Working knowledge of ISO 13485 and FDA QMSR (21 CFR Part 820), or a regulated‑industry quality system (e.g., ISO 9001 or equivalent) with the ability to apply it to medical device. Demonstrated ability to build, improve, and author quality processes and SOPs with senior individual‑contributor autonomy. Excellent interpersonal, written, and verbal communication skills. Preferred Direct experience in medical device manufacturing (Class II or Class III) under FDA QSR/QMSR or ISO 13485. Class III implantable or active implantable medical device (AIMD) manufacturing experience. Working knowledge of front‑end MEMS fabrication (photolithography, thin‑film deposition, plasma etch) and/or back‑end microelectronic device assembly (thermal compression bonding, dispense, laser dicing); contamination control and wafer‑level test and inspection. Computer System Validation (CSV) experience for production equipment software per GAMP 5 and/or 21 CFR Part 11. Experience assessing, maturing, and continuously improving a quality management system and the validation program supporting it. Working knowledge of risk management per ISO 14971, including design and process FMEAs. Working knowledge of Lean, Six Sigma, or equivalent operational‑excellence and structured problem‑solving methods. Quality‑engineering knowledge equivalent to ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA). Experience supporting design transfer and new product introduction (NPI) from R&D to production. Familiarity with electronic QMS (eQMS) and MES. Diverse workforces create the best culture, company, and products. We at Precision are committed to an inclusive culture that celebrates the uniqueness and contributions of everyone. As an equal opportunity employer, Precision does not discriminate on the basis of sex, race, religion, national origin, disability status, protected veteran status, or any other characteristic protected by law. For roles based in Massachusetts: it is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability. #J-18808-Ljbffr