Senior Product Quality Engineer

Responsibilities

• Audit and oversee Contract Manufacturers' Quality Management Systems for ISO 13485 and ISO 9001 compliance
• Manage CAPA and deviation processes to ensure systemic compliance
• Partner with CMs to vet Master Validation Plans and IQ/OQ/PQ protocols
• Monitor yields and optimize Quality Control Plans (IQC, IPQC, OQC)
• Own master Risk Management files and high-level FMEA documentation
• Drive alignment between Engineering and CMs to establish test thresholds during NPI
• Own the Reliability testing program and define Ongoing Reliability Testing (ORT) requirements
• Manage quality data reporting and build dashboards using CX/RMA data
• Perform physical product teardowns and Root Cause Analysis (RCA) on field failures

Requirements

• 4+ years as a Senior Product Quality Engineer
• 8+ years in new product development with Asian suppliers and high-volume electronic consumer products
• Strong knowledge of ISO 13485 and ISO 9001 frameworks
• Expertise in Data Analysis using Excel, SQL, or Python
• Experience leading RCA and hands-on failure analysis for electro-mechanical hardware
• Experience with high cavitation injection molding and machining processes
• Deep knowledge of materials, assembly, electronics, and production methods
• Ability to travel internationally 2-3 times per year
• Bachelor's or Master's degree in Mechanical or Biomedical Engineering

Preferred Qualifications

• Solidworks CAD experience
• Experience with motors and PCBAs
• Experience with IPX rated products

Benefits

• Hybrid working environment in DUMBO, Brooklyn
• Year-round early "summer Fridays"
• WiFi enabled rooftop