Position Overview:

The Director, New Product Introduction (NPI), Design Quality Assurance, is responsible for leading Design Quality Assurance (DQA) strategy and execution across all new product development programs, ensuring the compliant, efficient, and high‑quality introduction of medical devices into the market. This role oversees design quality activities spanning systems, software, hardware, digital applications, cloud components, and connected device ecosystems.

The Director provides strategic leadership to ensure that NPI programs meet global regulatory requirements, internal quality expectations, and product performance targets across Class I, II, and III medical devices. This includes establishing robust design control practices, driving cross‑functional integration quality, ensuring risk‑based decision‑making, and overseeing Design History File (DHF) completion and compliance.

This position requires a high level of technical depth across software, systems engineering, digital applications, and cybersecurity, combined with strong leadership capabilities to influence design quality across the organization. The Director partners closely with R&D, Systems Engineering, Software Engineering, Regulatory Affairs, Program Management, Manufacturing, and Operations to ensure end‑to‑end product quality and readiness for commercial launch.

Responsibilities:

• 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.

Education and Experience:

• 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.

Skills/Competencies:

• Strong communication and cross-functional leadership skills.

• Ability to influence senior engineering, program management, and business stakeholders.

• Expert understanding of systems engineering, Embedded products, digital/application development, and complex system interactions.

• Exceptional analytical and problem-solving capabilities with a systems-thinking approach.

• Ability to drive clarity, structure, and high-quality execution within complex and fast-paced development environments.

• Demonstrated ability to build, scale, and inspire high-performing technical teams.

• Strong organizational skills with the ability to manage multiple programs simultaneously.

• High level of accountability, resilience, and sound judgment in risk-based decision-making.

NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office. #LI-Hybrid

Additional Information:

Compensation & Benefits: For U.S.-based positions only, the annual base salary range for this role is $189,600.00 - $284,400.00 This position may also be eligible for incentive compensation. We offer a comprehensive benefits package, including: • Medical, dental, and vision insurance • 401(k) with company match • Paid time off (PTO) • And additional employee wellness programs Application Details: This job posting will remain open until the position is filled. To apply, please visit the Insulet Careers site and submit your application online. Actual pay depends on skills, experience, and education.