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
Education and Experience:
Bachelor of Science or equivalent degree in Software Engineering, Computer Science or related field is preferred
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
3+ years hands on experience in developing non-functional requirements and supporting system integrations including grey box testing
Minimum Requirements:
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; experience and capability 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
Preferred Skills and Competencies:
Master of Science degree is desired; System Engineering training and/or certification is a plus
Experience or formal training in established Systems Engineering concepts.
Prior experience integrating/testing cloud connected mobile applications on Android/iOS platforms a plus
Physical Requirements (if applicable):
None
NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office.
Additional Information:
Compensation & Benefits:
For U.S.-based positions only, the annual base salary range for this role is $112,600.00 - $168,850.00
This position may also be eligible for incentive compensation.
We offer a co
Additional Information
Job Summary
The Senior Systems Engineer plays a pivotal role in bringing Insulet's next-generation medical devices to life by driving the system-level design and integration that underpin innovative product development. This role exists to ensure that complex, multidisciplinary technologies come together seamlessly to deliver safe, reliable, and high-impact solutions for patients. By leading system thinking across hardware and software domains, this position directly contributes to accelerating innovation, strengthening product quality, and advancing Insulet's mission to transform diabetes care through cutting-edge technology.
Position Overview:
The Senior Systems Engineer is a member of the Systems COE and a technical expert responsible for supporting systems engineering activities for various applications newly developed and/or enhanced by the Mobile & Cloud Software Engineering group. The position will directly involve hands on development of system and software requirements, system architecture, non-functional requirements, grey box testing, integration testing for android and iOS mobile applications that support the Insulet Product Eco-System. Education and work experience should encompass an engineering discipline in computer science, systems engineering or related field and should have prior work experience in cloud-based products, mobile applications, understanding of data models, enterprise system performance and scalability. This position will report to Sr. Manager, Systems Engineering.
Insulet · US