Director, Design Quality Assurance – NPI

Role Overview

• Provide strategic leadership for NPI Design Quality Assurance across all new product development programs, ensuring high-quality and compliant product introductions.
• Direct Quality Core Team Members who serve as one quality POC for the NPI Core teams for E2E product delivery.
• Work very closely with DQA leadership team for forming an extended quality core teams for each of the NPI program for successful end-to-end engagement.
• Develop and deploy DQA strategies, frameworks, and processes aligned with company goals, regulatory expectations, and industry best practices for medical device development.
• Ensure compliance with global regulations and standards (FDA, ISO 13485, ISO 14971, IEC 62304, IEC 82304) for Class I, II, and III medical devices.
• Oversee all system components within NPI programs to ensure seamless integration, robust system performance, and compliance with safety and regulatory expectations.
• Oversee design controls, risk management, usability engineering, cybersecurity, AI/ML validation, and ensure timely and compliant completion of Design History Files (DHF).
• Drive end-to-end quality throughout the product lifecycle, including Product planning, system architecture reviews, requirements development, system interactions, data flows, and interoperability across system components.
• Partner with Systems Engineering to ensure system decomposition, interface specifications, and integration activities meet quality and regulatory expectations.
• Apply advanced technical expertise in software engineering, architecture assessment, verification strategy, tool validation, and cybersecurity risk evaluation to guide cross-functional teams.
• Lead cross-functional integration quality efforts across hardware, firmware, digital applications, cloud environments, and enterprise systems.
• Oversee risk-based decision-making, defect management, and software and system risk assessments to ensure product safety and regulatory compliance.
• Ensure enterprise readiness for internal and external audits, FDA inspections, and notified body assessments.
• Build, mentor, and develop a high-performing DQA organization comprising of QCTMs.
• Drive continuous improvement of quality systems, design control processes, tools, templates, and digital quality capabilities to support operational excellence.
• Serve as a senior subject matter expert in design quality assurance, guiding leadership teams, development organizations, and external partners.
• Oversee the development and delivery of training related to Design Controls, software quality, systems quality, digital compliance, and NPI best practices.
• Establish and lead metrics/KPIs for DQA performance, providing executive-level insights and driving continuous improvement initiatives across the product lifecycle.
• Other duties as assigned.

Requirements

• Bachelor’s or Master’s degree in Engineering, Computer Science, Biomedical Engineering, or related technical discipline
• 12+ years of experience in design quality assurance, NPI quality, or related engineering functions within the medical device industry
• • years of leadership experience managing cross-functional quality teams in a regulated environment
• Proven experience leading NPI programs with complex system architectures, digital applications, cloud/software components, and connected medical devices.
• Strong expertise with FDA 21 CFR Part 820, ISO 13485, ISO 14971, IEC 62304/82304, IEC 60601, and relevant FDA/EMA regulatory guidance.
• Demonstrated experience with design controls, DHF management, risk management, verification/validation strategy, and readiness for regulatory submissions (510(k), PMA, technical files).
• Deep working knowledge of software engineering principles, mobile development frameworks, cloud services (AWS/Azure), APIs, and digital connectivity.
• Strong understanding of Agile development, SDLC tools, and modern DevOps practices.
• Experience leading enterprise or portfolio-level quality initiatives and driving process transformation.

Tech Stack

• AWS
• Azure
• Cloud
• Cyber Security
• SDLC

Benefits

• Medical, dental, and vision insurance
• 401(k) with company match
• Paid time off (PTO)
• And additional employee wellness programs