Senior Product Quality Engineer

Responsibilities

• Audit and oversee Contract Manufacturers' Quality Management Systems to ensure strict adherence to ISO 13485 and ISO 9001 standards.
• Own and manage the CAPA and deviation processes to ensure systemic compliance and continuous improvement.
• Conduct supplier audits and track systemic CM performance.
• Partner with CMs to vet and sign off on Master Validation Plans and IQ/OQ/PQ protocols during product setup.
• Transition these into production by reviewing and optimizing the CM’s ongoing Quality Control Plans (IQC, IPQC, OQC).
• Monitor yields and limit samples to ensure the factory consistently builds to spec and never ships defective product.
• Own the master Risk Management files and high-level FMEA documentation.
• Participate and sign off in new product development.
• Work closely with the design team and suppliers during NPI to transfer critical design requirements into assembly and testing fixtures.
• Review early test data, driving alignment between Engineering and CM’s to establish test thresholds that are sensitive enough to intercept defects, while aligning with the supplier’s true process capability.
• Own the Reliability testing program.
• Define Ongoing Reliability Testing (ORT) requirements for factory partners and monitor long-term durability and "wear and tear" trends.
• Quality Data Reporting & Prioritization: Own the "Single Source of Truth" for quality. Manage the ingestion of CX/RMA data, build reporting dashboards, and provide data-driven direction on where to focus engineering investigations.
• Collaborate with the engineering team in physical product teardowns and Root Cause Analysis (RCA) of field failures and customer returns.
• Support regulatory-related documentation and process needs, building familiarity with applicable requirements over time.

Requirements

• 4+ years in Senior Product Quality Engineer
• 8+ years Experience working in new product development with Asian suppliers and contract manufacturers with a focus on high-volume electronic consumer products
• Strong working knowledge of ISO 13485 and ISO 9001 frameworks, with demonstrated experience auditing medical device or high-compliance consumer electronics Contract Manufacturers.
• Expertise in Data Analysis (Excel, SQL, Python) to visualize quality trends.
• Demonstrated experience leading Root Cause Analysis (RCA) and hands-on failure analysis/product teardowns for electro-mechanical hardware.
• High cavitation injection molding and machining process experience
• Deep knowledge of materials, processes, assembly, electronics, and production methods
• Strong communication skills to present quality risks to executive leadership
• Ability to travel internationally 2-3 times per year to be on-site at suppliers
• Ability to attend evening calls with suppliers 1-2 nights per week
• Bachelor’s (B.S.) or Masters Degree in Mechanical or Biomedical Engineering

Benefits

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• Hybrid working environment, with an office located in the heart of DUMBO with breathtaking views of Manhattan Bridge
• Year round early “summer Fridays”
• WiFi enabled rooftop