Staff Quality Assurance Engineer (Hybrid - San Diego, CA)

Job Summary

Position Overview:
This position leads Design Quality Assurance (DQA) and Quality Engineering activities across the full product development lifecycle for medical devices, including system, hardware, and software components, as well as supporting quality system processes and automated tools. The role ensures compliant and efficient execution of design controls in alignment with applicable regulations, standards, and internal procedures, while driving continuous improvement to enhance product quality, process effectiveness, and scalability.

The Staff DQA Engineer is responsible for integrating design controls, system-level risk management, and verification and validation (V&V) into a cohesive, end-to-end framework with clear traceability and technical rigor. This role serves as a subject matter expert, partnering cross-functionally with R&D, Systems Engineering, Hardware and Software Engineering, IT/Cybersecurity (as applicable), Manufacturing, Human Factors, Regulatory Affairs, and external stakeholders to embed quality early in development and ensure successful product realization and lifecycle management.

Responsibilities:
• Lead Design Control and Quality Engineering activities for FDA Class II and III medical devices, ensuring complete and compliant Design History File (DHF) documentation across system, hardware, and software.
• Ensure compliance with applicable regulations and standards (e.g., FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, IEC standards) while embedding quality throughout the product development lifecycle.
• Drive integrated system-level risk management, ensuring end-to-end traceability from hazards through risk controls to verification and validation across all product domains.
• Provide subject matter expertise in design controls, risk management, system requirements, architecture, and V&V strategies, including hardware, software, and system integration testing.
• Review and provide high-quality feedback on requirements, specifications, design documentation, risk management files, validation protocols, test plans, and reports.
• Partner cross-functionally with Engineering and Project Management to ensure effective design control execution and early embedding of quality.
• Establish, standardize, and continuously improve design control, risk management, and quality processes—driving simplification, harmonization, and efficiency across teams.
• Identify systemic gaps and inefficiencies and lead data-driven continuous improvement initiatives with measurable outcomes.
• Define, monitor, and leverage quality and process performance metrics to drive sustained improvement and organizational learning.
• Institutionalize improvements through procedures, governance, and training, including development and delivery of targeted training programs.
• Other duties as assigned.

Education and Experience:
• Bachelor’s degree in engineering, Life Sciences, or related field (master’s preferred)
• 8+ years of experience in the medical device industry, with strong knowledge of design controls and quality systems.
• Proven track record in leading cross-functional continuous improvement projects.
• Deep understanding of regulatory standards (FDA QSR, ISO 13485, ISO 14971, IEC 62304, etc.).
• Experience implementing SDLC best practices in regulated environments.
• Lean Six Sigma certification (Green Belt or higher) preferred.
• Excellent communication, leadership, program management and stakeholder management skills.

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.
• 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.

Job Title:                        Senior Staff SW Design Quality Assurance Engineer

Department:                 Design Quality Assurance

FLSA Status:                   Exempt

Position Overview:
This position is responsible for leading Quality Assurance and Quality Engineering activities throughout the Software Development Lifecycle for new product development initiatives and for automated data processing systems used as part of the quality system. This includes ensuring that the software development process is compliant with applicable standards, regulations and guidance documents for medical devices including supporting the Cyber security development processes and Cyber Bill of Materials.  This role will interface with other Insulet departments (e.g. Research and Development, IT-Cybersecurity, Sustaining, Engineering, Human Factors, and Regulatory Affairs) as well as other external parties on issues related to product development, launched product support, and software used for automation of the quality system.

Responsibilities:

• Lead Design Control and Software Development initiatives to develop appropriate Design History File documents for FDA Class II and Class III medical devices, mobile applications, cloud-based systems, and cybersecurity.
• Ensures compliance to IEC 62304, and FDA Guidance on Software Contained in a 510(k) Submission.
• Support efforts for cybersecurity risk management for both US and Rest of World (ROW) requirements.
• Support development teams on the validation of software tools.
• Provide guidance for the generation, review, and approval of design control documentation with primary focus on software development deliverables.
• Collaborate with Project Management to support the Design Control process and Continuous Improvement initiatives to optimize our SW Development processes.
• Serve as the Design Control expert to software development organization.
• Develop and deliver Design Control training for the software development organization.
• Provide expertise in establishing good software requirements, specifications, detailed design, verification and validation protocols and planning documentation.
• Review requirements, specifications, product design documents, validation protocols, test plans, test cases, and other documentation as required and provide timely feedback.
• Support creation of necessary documentation to comply with regulatory requirements and industry best practices.
• Support execution of Risk Management Activities for complex systems in compliance with ISO14971 and software risk requirements in IEC 62304
• Establish and maintain software quality assurance processes, procedures, and controls to ensure compliance with FDA regulations and established standards such as IEC 62304
• Provide guidance on, and participate in software development activities including design and code reviews, requirements analysis and tracing, defect tracking and configuration management
• Applies a good working knowledge of Software Development Life Cycle (IEC 62304), Design Controls (ISO 13485) and other regulatory requirements and agencies as it relates to Quality Assurance activities in software development. Maintain effective communication with the project software engineers to make sure that user needs, requirements, plans, verification and validation documents, risk assessments, and other documentation is complete.

Education and Experience:

• ASQ, CSQE or other software quality certificates are beneficial.
• BS degree in an engineering, scientific, computer systems, or quality management curriculum or equivalent experience.  Master’s degree preferred.
• Experience with medical device software development.
• Experience with a risk-based approach to validate Commercial off the Shelf (COTS) software and SW Tools.
• Experience with software mobile applications, cloud-based systems, and cybersecurity.

• A minimum of 8 years work experience in Software Quality Engineering within an FDA, ISO, or other regulated environment and/or equivalent combination of education and experience.

• 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, 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.
• 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.

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.