Senior Quality Engineer (Medical Devices)

Location: On-site in San Diego, California; must be located within commuting distance. Up to 20% travel is expected, primarily for contract manufacturer visits and supplier audits.

Salary: $130,000–$150,000 annually, depending on experience, skills, and qualifications. Discretionary bonuses and/or equity grants may also be available.

Company

hirify.global develops non-surgical brain–computer interfaces and safety-critical medical technologies designed to restore digital interaction and preserve autonomy for people with paralysis or cognitive decline.

What you will do

• Lead design quality activities across product development programs from concept through commercialization.
• Manage design reviews, verification and validation, Design History Files, traceability, engineering change assessments, and product documentation.
• Facilitate risk management activities, including hazard analyses, risk assessments, FMEAs, and verification of risk controls.
• Support design transfer, process validation, equipment qualification, pilot builds, and manufacturing readiness.
• Collaborate with suppliers, contract manufacturers, Operations, R&D, Manufacturing Engineering, Clinical, and Regulatory Affairs.
• Support audits, FDA inspections, CAPAs, nonconformance investigations, and continuous improvement of the Quality Management System.

Requirements

• Bachelor’s degree in mechanical engineering, biomedical engineering, electrical engineering, or a related technical or science field.
• 7+ years of Quality Engineering experience in an FDA-regulated medical device environment.
• Experience with new product development, design controls, risk management, verification and validation, and design transfer.
• Strong knowledge of FDA 21 CFR Part 820, ISO 13485, ISO 14971, and applicable product standards.
• Experience with Design and Process FMEAs, supplier quality, contract manufacturing, process validation, and manufacturing quality strategies.
• Strong technical writing, documentation, communication, and multidisciplinary collaboration skills.

Nice to have

• Experience supporting Class III medical devices.
• ISO 13485:2016 Lead Auditor certification or willingness to obtain one.
• CQE or CQA certification.
• Experience interpreting engineering drawings, GD&T, and product specifications.

Culture & Benefits

• Full-time, exempt W-2 employment in the United States.
• Subsidized medical and dental insurance for employees and dependents.
• Life insurance and short- and long-term disability coverage.
• 401(k), flexible spending account, discretionary unlimited PTO, and commuter benefits for New York employees.
• Visa sponsorship is not available for this position.