Senior Software Requirements Analyst, Cloud (Hybrid)

Responsibilities

• Responsible for the development of software requirements by analyzing user needs and product requirements
• Lead and drive the technical reviews of software requirements with the required stakeholders from various cross functional teams
• Create and maintain traceability matrices between requirements, design verification outputs, risk management artifacts, and software design outputs in compliance with FDA guidelines
• Generate requirement traces and reports as needed for regulatory submissions
• Manage software requirements and traceability in Insulet's PLM and ALM tools, including version controlling of the documents
• Review and consult with Product Owners on user stories that incorporate software requirements, ensuring sufficient detail is provided to guide the Agile development teams.
• Review downstream engineering teams' development artifacts such as design/architecture documents, design failure mode analysis to ensure implementation meets the specified requirements
• Review software test deliverables such as test strategy and test cases to ensure alignment with the requirements
• Education and Experience
• Bachelor of Science or equivalent degree in (Systems, Biomedical, Computer Science) discipline or related engineering/technical degree is preferred
• Minimum Five (5) years of experience working on the technical aspects of cloud or cloud integrated products preferred.
• Required Skills and Competencies
• Highly skilled in requirements writing and analysis for functional and non-functional software requirements, documentation, and traceability, including system and/or software requirements, and data analysis for complex systems in a multidisciplinary team environment
• Domain expertise in one of more associated domains; preferably Software Engineering, with prior experience working in Cloud based Systems
• Thorough understanding of web services, microservices, HTTP protocols, and REST
• Demonstrated understanding of database concepts and usage
• Demonstrated understanding of Systems Engineering practices, such as requirements management, risk analyses, and system and / or software architecture
• Working knowledge of application lifecycle management tools (Polarion ALM, Helix ALM, Doors)
• Excellent project team and collaboration skills; experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team, including software developers, systems engineers, Product Owners, and design quality experts
• Contribute to continuous improvement efforts related to requirements and requirement management tools
• Experience working in Agile development environments

Requirements

• Formal training in established Systems Engineering concepts
• Any Formal training or requirement development related certification
• Knowledge of diabetes management products
• Experience with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls)
• Experience with change orders within a Product Lifecycle Management (PLM) tool
• Knowledge of introducing innovative FDA regulated medical devices to market
• General understanding of communication, data analytics, mobile technology, IoT (Internet of Things), GDPR; a strong plus
• Very detail oriented, ability to work independently with minimal supervision, self-motivated and ability to carry out impact assessment across sub systems
• Required Leadership/Interpersonal Skills & Behaviors
• Effectively manage stakeholders' expectations and drive team decisions.
• Communicate effectively to multiple levels in the organization and provide status reports to management
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Benefits

Additional Information

Job Summary The Senior Systems Engineer is instrumental in advancing Insulet's ability to deliver innovative, next-generation medical devices by ensuring complex technologies are brought together into cohesive, high-performing solutions. This role is critical to transforming early-stage product concepts into scalable, reliable systems that meet the demands of patients and the healthcare environment. By driving alignment across diverse engineering domains, this position directly enhances Insulet's capacity to accelerate innovation, elevate product quality, and maintain its leadership in creating life-changing diabetes management technologies. Position Overview The Senior Software Requirements Analyst, Cloud, will be leading and driving the development and analysis of software requirements supporting the software development life cycle of Insulet's innovation pipeline of Cloud to mobile devices integrations, Cloud scalability and enhancements, Partner Integrations for data management and analytics, CRM integrations. Please note that this is not a DEV OPS role

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