Staff Design Quality Engineer (Medical Devices)

TL;DR

Staff Design Quality Engineer (Medical Devices): Leading design quality activities for hardware and software medical devices with an accent on design controls, risk management, AI/ML-enabled products, and regulatory compliance. Focus on coordinating cross-functional investigations, validating complex medical technologies, and resolving customer and manufacturing quality issues.

Location: Hybrid role based in the United States, with two to three days per week in the office in New York City, Burlington, Massachusetts, or the San Francisco Bay Area. Candidates must be authorized to work in the United States; immigration sponsorship is not available.

Salary: Approximately $145,000 plus bonus, equity, and benefits in New York City or Burlington; approximately $160,000 plus bonus, equity, and benefits in San Francisco.

Company

hirify.global develops portable ultrasound devices, ultrasound semiconductor technology, cloud software, and AI-powered medical imaging solutions.

What you will do

• Lead design quality activities for new hardware and software medical device development and sustaining product-line work.
• Coordinate cross-functional teams across R&D, engineering, manufacturing, regulatory, clinical, quality, program management, suppliers, and customer-facing functions.
• Advise teams on design controls, risk management, human factors, usability engineering, cybersecurity, AI/ML validation, and verification and validation.
• Support customer complaint investigations, hardware failures, manufacturing escapes, corrective actions, and product risk mitigation.
• Prepare quality metrics, executive-ready updates, and customer-facing communications to drive continual improvement.
• Support regulatory, notified body, FDA, internal, customer, supplier, and contract manufacturer audits.

Requirements

• Bachelor’s degree in engineering, life sciences, biomedical engineering, quality, or a related technical field.
• Experience in design quality, quality engineering, product development, systems engineering, software quality, AI/ML quality, hardware quality, or a related role in a regulated industry.
• Strong knowledge of medical device design controls, ISO 14971 risk management, FDA 21 CFR Part 820, and ISO 13485.
• Experience with AI/ML-enabled medical devices or regulated software, including data quality, model performance, monitoring, bias, generalizability, and algorithm change management.
• Strong proficiency with 8D problem-solving, root cause analysis, containment, corrective and preventive actions, and effectiveness checks.
• United States work authorization is required; hirify.global does not provide immigration sponsorship.

Nice to have

• Experience with Class II or Class III medical devices, SaMD, imaging systems, diagnostic platforms, connected devices, or clinical decision support products.
• Experience with semiconductor manufacturing, PCBA, electronics reliability, hardware customer quality, or contract manufacturer quality.
• Knowledge of IEC 62304, IEC 62366, AAMI TIR57, AAMI TIR97, EU MDR, IEC 60601, and medical device cybersecurity guidance.
• Experience with eQMS, PLM, requirements management, model lifecycle management, data analytics, or risk management tools.
• ASQ, Six Sigma, RAC, or another relevant quality or regulatory certification.

Culture & Benefits

• Hybrid work environment designed to support collaboration and in-person connection.
• Health, dental, vision, and annual HSA contributions.
• 401(k) plan with company match and employee stock purchase plan eligibility.
• Unlimited paid time off, ten annual holidays, and parental leave.
• Equity participation and the opportunity to build healthcare products for medical imaging.