About the role

Senior Systems Engineer supporting cloud-based mobile applications at Insulet. Collaborating with cross-functional teams and ensuring system performance and safety compliance.

Responsibilities

Serve as a key member of a cross-functional project team consisting of software, analytics, Site reliability engineers, Cloud Operations, Medical, Marketing, Data engineering, Privacy, Regulatory, Product owners, Product Managers and quality engineers to achieve project deliverables
Lead system definition tasks such as generating user needs, product/system requirements, software requirements and use-case descriptions
Contribute to system development by defining system and subsystem architecture
Identify and document System Hazard Analysis, failure modes and risk mitigation
Provide system impact and safety risk assessment of component failure modes as input to DFMEA
Triage and/or troubleshoot production issues and incorporate into requirements and risk documents
Develop performance models and non-functional requirements in support of system scalability and performance
Serve as technical consulting resource for integration, subsystem and system verification activities creating integration plans, perform review of test coverage and hands on integration testing
Create and maintain traceability among design input, design output, verification and validation, and risk management artifacts to ensure completeness and fully traceable design history file
Participate in review of data models and generate data mapping, data driven requirements as needed. Work with data engineering and architecture team to generate data specification

Bachelor of Science or equivalent degree in Software Engineering, Computer Science or related field is required
5-7 years of overall experience in software industry in engineering or related roles
5 + years of experience working as a Systems engineer in enterprise applications, or related
3+ years hands on experience in developing non-functional requirements and supporting system integrations including grey box testing, or related
Demonstrated expertise in Systems Engineering practices such as requirements management, design trade-off and cost-benefit analysis, hazards and risk assessments
Experience writing verification plans, protocols and reports in a regulated industry
Proficient with Medical Device regulations (IEC 62304, 21 CFR part 820.30-Design Controls)
Excellent project team skills working collaboratively under a Quality Management System (QMS), as part of a cross-functional team that includes development, verification/validation, marketing, clinical, regulatory and quality experts
Good understanding of web services, microservices, HTTP protocols, REST APIs, SOA
Familiarity with database concepts and usage
Exposure to data models, data driven requirements and data governance