Senior Systems Business Cloud Engineer (Remote/Flexible)

Company Overview

Insulet started in 2000 driven to achieve our mission of enabling our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients who have insulin-requiring diabetes, by using innovative technology that is wearable, waterproof, and lifestyle accommodating. We are on an exciting trajectory of significant growth and global expansion enabling us to reach more patients around the globe.

We are looking for highly motivated, performance driven individuals who want to be part of building our Systems Engineering Center of Excellence and be at the forefront of our rapidly growing global footprint. We are looking to hire amazing people who are guided by shared values and desire to exceed customer expectations. Our continued success depends on it.

Position Overview

The Senior Software Requirements Analyst 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. This position is not a DevOps position and the primarily responsibility is to develop solid Software requirements for Cloud based projects.

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 required 
• A minimum of five (5) years of experience working on the technical aspects of cloud or cloud integrated products 

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.

 Preferred Qualifications  

• 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