Staff Software DQA Engineer - Partner Management (Hybrid - San Diego, CA)

Insulet Corporation•San Diego, CA

2d•Hybrid

About The Position

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.

Requirements

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.).
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.

Nice To Haves

ASQ, CSQE or other software quality certificates are beneficial.

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.