Position Overview:

The Director, Design Quality Assurance - Digital Products, is responsible for leading Quality Assurance and Quality Engineering activities across the Software Development Lifecycle for both new product development and sustaining programs involving digital medical products. These include cloud-based platforms, mobile applications, connected devices, and Software as a Medical Device (SaMD), as well as automated data processing systems used within the quality system.

This role ensures that software development and deployment processes meet all applicable regulatory, cybersecurity, and quality standards, including FDA, ISO 13485, ISO 14971, IEC 62304/82304, and guidance related to AI/ML and cybersecurity/product security. The Director will guide cloud development activities and ensure quality in the deployment of cloud-related medical devices and their interactions with enterprise IT infrastructure.

The position requires hands-on technical expertise, deep process knowledge of Class II and III medical devices, and advanced capabilities in AI-driven Digital Quality Assurance (DQA). The Director will work cross-functionally with R&D, Systems Engineering, IT-Cybersecurity, Human Factors, Regulatory Affairs, and other internal and external stakeholders to ensure seamless integration of digital products into broader system architectures. A key focus will be on ensuring interoperability, system-level quality, and risk-based decision-making in a fast-paced, agile environment.

Responsibilities:

Direct the Design Assurance organization to support new product development and sustain activities for digital and cloud-based medical products.

Develop and implement comprehensive design quality strategies, ensuring alignment with company goals, industry standards, and regulatory requirements.

Ensure compliance with global regulations and standards (FDA, ISO 13485, ISO 14971, IEC 62304, IEC 82304) for Class II and III devices.

Oversee design controls, risk management, usability, cybersecurity, and AI/ML validation throughout the product lifecycle.

Guide cloud development activities and ensure quality in the deployment of cloud-related medical devices and their interactions with enterprise IT infrastructure.

Ensure seamless integration of digital products with broader system components including hardware, firmware, and enterprise platforms.

Apply risk-based decision-making and lead risk assessments to support innovation, safety, and compliance.

Lead internal and external audit readiness, including FDA inspections and notified body assessments.

Hire, develop, and retain top DQA talent while fostering a high-performance, agile, and collaborative team culture.

Continuously improve quality systems, tools, and processes to support digital product excellence in a fast-paced environment.

Establish and maintain software quality assurance processes, procedures, and controls to ensure compliance with FDA regulations and established standards such as IEC 62304.

Serve as a subject matter expert on SW design quality matters, providing expertise and support to cross-functional teams and external partners.

Develop and deliver Design Control training for the software development organization.

Establish and maintain design quality, SW metrics and key performance indicators, conducting regular reviews and analyses to drive continuous improvement initiatives.

Education and Experience:

Bachelor’s or Master’s degree in Engineering, Computer Science, Biomedical Engineering, or related field.

10+ years in software design quality assurance within the medical device or medical digital health industry.

7+ years in a leadership role overseeing design quality and/or DQA for digital products.

Significant breadth and depth in quality decision-making, risk management, and quality engineering.

Experience with software mobile applications, cloud-based systems, and cybersecurity.

Experience in the development and implementation of effective Design Control Systems.

Working knowledge of the Quality System Regulation (FDA 21 CFR Part 820) and ISO 13485 quality system standards.

Working knowledge of IEC 62304/82304, ISO 14971, IEC 62366, IEC 60601, and FDA guidance documents on software development, cybersecurity, and submission requirements for 510(k).

Familiarity with various software development tools (e.g. configuration management, issue/defect tracking, requirements analysis, etc.).

Experience with software development lifecycles with emphasis on the software quality engineering aspects.

Skills/Competencies:

Effective verbal and written communication skills.

Experience collaborating and communicating with individuals at multiple levels in an        organization.

Ability to prioritize and manage critical project timelines in a fast-paced environment. Must be able to handle multiple responsibilities concurrently.

Conflict resolution skills including persuasive management techniques required.

Strong analytical and problem-solving skills.

Able to work effectively in a high-stress, high-energy environment.

Ability to influence people and projects in a fast-moving environment.

Additional Information:

The US base salary range for this full-time position is $168,075.00 - $252,112.50. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position in the primary work location in the US. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. Your Talent Acquisition Specialist can share more about the specific salary range for your preferred location during the hiring process. Please note that the compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits.

Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. For more information, please visit insulet.com and omnipod.com.

We are looking for highly motivated, performance-driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!

At Insulet Corporation all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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