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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:

• BS degree in computer science, computer engineering or equivalent field. Master's degree preferred.

• Experience with medical device software development. Cloud software in medical device preferred.

• 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.

• ASQ, CSQE or other software quality certificates are beneficial.

NOTE: This position is eligible for hybrid working arrangements (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.

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