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
