Job Title: Staff Software Design Quality Assurance Engineer - Partner Management
Department: Design Quality Assurance
FLSA Status: Exempt
Position Overview:
The Staff Software Design Quality Assurance Engineer – Partner Management is responsible for leading Quality Assurance and Quality Engineering activities across the Software Development Lifecycle for both new product development and sustaining programs involving integration and interoperability with Insulet’s partners. These include connected hardware devices, cloud-based platforms, mobile applications, and Software as a Medical Device (SaMD).
This role ensures shared compliance (Insulet and partners) with 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 Quality Engineer will guide development activities and ensure quality in Insulet’s interoperable products and services.
The position requires knowledge of Class II and III medical devices. The Design Quality Engineer 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, inclusive of partner components and systems. A key focus will be on ensuring interoperability, system-level quality, and risk-based decision-making in a fast-paced, agile environment.
Responsibilities:
Represent Design Assurance organization to support new product development and sustain activities for partner integration products and features.
Support partner-focused design quality strategies, ensuring alignment with company goals, industry standards, and regulatory requirements.
Ensure shared compliance with global regulations and standards (FDA, ISO 13485, ISO 14971, IEC 62304, IEC 82304) for Class II and III devices.
Support design controls, risk management, usability, cybersecurity, and AI/ML validation for interoperable products and systems throughout the product lifecycle.
Ensure seamless integration of digital products with partner system components including hardware, firmware, and enterprise platforms.
Continuously improve partner-relevant processes to support product excellence in a fast-paced environment.
Serve as a subject matter expert on existing partner integrations, providing expertise for pre/post-market risk assessments and support to internal/external design teams.
Lead alignment efforts with Insulet QA/RA leadership to resolve emerging partner issues, confirm strategic direction, and deliver consistent messaging to external partners.
Maintain partnership quality metrics and key performance indicators, conducting regular reviews and analyses to drive continuous improvement initiatives.
Manage the QMS process for inbound/outbound partner communications, assessments, and records retention.
Other duties as assigned.
Education and Experience:
Bachelor’s degree in Engineering, Computer Science, Biomedical Engineering, or related field; masters degree preferred.
8+ years in design quality assurance within the medical device or medical digital health industry, preferably software focused.
Experience with medical device / regulated software development lifecycles with emphasis on the software quality engineering aspects.
Experience in the development and implementation of effective Design Control Systems.
Exposure to quality decision-making, risk management, and quality engineering.
Experience with software mobile applications, cloud-based systems, and cybersecurity.
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.).
ASQ, CSQE or other software quality certificates are beneficial.
Skills/Competencies:
Excellent verbal and written communication skills.
Experience collaborating and communicating with individuals at multiple levels within and outside an organization.
Ability to prioritize and manage critical project timelines in a fast-paced environment. Must be able to handle multiple responsibilities concurrently.
Strong analytical and problem-solving skills.
Able to work effectively in a high-stress, high-energy environment.
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 $117,700.00 - $176,500.00 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.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.