Insulet
Medical Device
SeniorSoftwareRequirementsAnalyst,Cloud
“Senior Software Requirements Analyst, Cloud at Insulet. Skills: Requirements Analysis, Cloud Systems, Systems Engineering, Agile Development. Develop software requirements by analyzing user needs. Lead technical reviews of software requirements”
What You'll Achieve.
Ensure complex technologies are brought together into cohesive, high-performing solutions; Deliver innovative, next-generation medical devices; Transform early-stage product concepts into scalable, reliable systems; Enhance Insulet’s capacity to accelerate innovation; Elevate product quality; Maintain its leadership in creating life-changing diabetes management technologies; Support the software development life cycle of Insulet’s innovation pipeline; Ensure implementation meets the specified requirements; Ensure alignment with the requirements
Industry & Context.
Analyze user needs; Analyze product requirements; Data analysis for complex systems; Risk analyses; Impact assessment across sub systems
Travel is estimated at 10%, Requires on-site work from an Insulet office
What They're Looking For.
Must Have
Bachelor of Science or equivalent degree in (Systems, Biomedical, Computer Science) discipline or related engineering/technical degree, Minimum Five (5) years of experience working on the technical aspects of cloud or cloud integrated products, 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 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 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, Effectively manage stakeholders' expectations and drive team decisions, Facilitate technical review meetings and explain content to technical and non-technical audience members including but not limited to software, analytics, Site reliability engineers, Cloud Operations, Clinical, Medical, Marketing, Data engineering, Privacy, Regulatory, Product owners and Product Managers, Communicate effectively to multiple levels in the organization and provide status reports to management, Organize and judge priorities in a dynamic environment. Flexible to change, Build and maintain working relationships with colleagues in a hybrid and remote work environment with resources spread across different time zones, Demonstrated skills with managing multiple tasks, highly adaptive mindset with ability to judge and set priorities
Nice to Have
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), a plus
What You'll Do.
Develop software requirements by analyzing user needs
Lead technical reviews of software requirements
Create and maintain traceability matrices
Generate requirement traces and reports for regulatory submissions
Manage software requirements and traceability in PLM and ALM tools
Review user stories with Product Owners
Review downstream engineering artifacts
Review software test deliverables
How You'll Work.
Team & Collaboration
Drive alignment across diverse engineering domains; Work collaboratively under a Quality Management System (QMS); Work with software developers, systems engineers, Product Owners, and design quality experts; Facilitate technical review meetings with various stakeholders; Build and maintain working relationships with colleagues in a hybrid and remote work environment
Communication Scope
Communicate effectively to multiple levels in the organization; Provide status reports to management; Explain content to technical and non-technical audience members
Process & Methodology
Manage software requirements, Manage stakeholders' expectations, Organize and judge priorities, Manage multiple tasks
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