Sr. Software Systems Engineer, Cloud (Hybrid) Acton, Mass. or San Diego, CA

Insulet Corporation•San Diego, CA

4d•Hybrid

About The Position

The Sr. Software Systems Engineer, 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

Requirements

Bachelor of Science or equivalent degree in (Systems, Biomedical, Computer Science) discipline or related engineering/technical degree
A minimum of 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 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
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 strong 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 Haves

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

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