- Job title
- Senior Quality Engineer
- Job location
- Menlo Park, CA, US
- Job description
- We're looking for a Senior Quality Engineer to own quality on a mid-field MRI system as we drive toward a 510(k) submission. This is a foundational hire: you'll stand up and run the quality management system, design controls, and risk management that turn breakthrough engineering into a safe, cleared medical device — and you'll set the standard the rest of the team builds to. You'll work hands-on and cross-functionally with engineering, advise leadership on regulatory strategy, and be the person accountable for getting us to submission the right way. If you're a senior quality professional who wants ownership from day one, thrives in a fast-paced startup, and wants to see your work reach patients — this is for you. This is not your typical quality role. You will lead and shape our strategy, have true impact, and not sit on the sidelines.
## Benefits
* Comprehensive health and dental coverage
* 401(k) with company match (100% on first 3% contributed, 50% on next 2%, up to 4% total)
* Daily lunch provided
* Monthly gym membership reimbursement
* PTO: Unlimited
Location: In-person at Menlo Park, CA offices
## What You'll Do
* Stand up and maintain our quality management system, aligned to ISO 13485 and the FDA Quality Management System Regulation, or QMSR (21 CFR 820)
* Lead design verification and validation activities and keep the Design and Development File / DDF (formerly the Design History File) complete, current, and audit-ready
* Own risk management per ISO 14971 — hazard analysis, risk assessments, and the risk management file — and lead risk management reviews of traceability matrices to ensure requirements are correctly linked to verification and validation records
* Author and maintain SOPs, work instructions, and quality plans that close compliance gaps before they become problems
* Own and drive NCRs, CAPAs, deviations, and design change / change order (CO) records through to closure
* Perform standards analysis and work directly with engineering on the approach to compliance for applicable safety standards (e.g., IEC 60601-1, IEC 60601-2-33 for MRI equipment, IEC 62304 for device software, and relevant MRI-related NEMA standards)
* Review verification objective evidence and write design inspection protocols for compliance to standards
* Lead preparation of the 510(k) submission and the design/quality documentation behind it
* Advise leadership on pre- and post-market regulatory strategy and quality risk
* Lead in-house audits and testing, and prepare for, host, and act as primary point of contact for external audits and inspections
* Provide quality guidance across engineering and other functional groups, identify the root sources of quality problems, and design corrective action programs
## What We're Looking For
* General Requirements:
* Work authorization
* Strong problem-solving skills and exceptional attention to detail
* Ability to work independently and lead cross-functionally in a fast-paced startup environment
* Clear written and verbal communication, including the ability to write technical and regulatory documents and advise leadership
* Open to candid, constructive criticism
* Self-starter comfortable operating with ambiguity and little precedent
* Technical Background:
* Bachelor of Science or higher in engineering or a related field
* At least 5 years of experience in quality engineering / quality assurance for medical devices, including hands-on design-control and risk-management work
* Working knowledge of ISO 13485 (QMS), ISO 14971 (risk management), and IEC 62304 (medical device software life cycle)
* Familiarity with medical electrical equipment safety standards — IEC 60601-1, IEC 60601-2-33 (MRI), IEC 62368-1 — and MRI-related NEMA standards
* Working knowledge of FDA design controls (21 CFR 820.30), 21 CFR 820 (QMSR), MDR/recall requirements, and the 510(k) process
* Ability to read, analyze, and interpret engineering drawings and technical, scientific, and regulatory documents
* Bonus Points:
* Direct experience preparing for or leading FDA inspections, MDSAP audits, or ISO 13485 audits, and communicating with regulatory authorities
* Familiarity with international regulatory frameworks
* Hands-on experience in the MRI or medical imaging space
* Experience as the founding or first quality hire at an early-stage medical device company
