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 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
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 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
NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office 3x/week; may work remotely other days). #LI-Hybrid
Additional Information:
Compensation & Benefits:
For U.S.-based positions only, the annual base salary range for this role is $112,600.00 - $168,
Benefits
Remote work options
Additional Information
Job Summary
The Senior Systems Engineer is a key driver of Insulet's ability to transform innovative concepts into fully integrated, market-leading medical devices that improve the lives of people with diabetes. This role is vital to ensuring that complex technologies come together seamlessly across disciplines, enabling the development of safe, reliable, and high-quality products. By influencing the foundation of new product development, this position directly impacts Insulet's speed of innovation, product excellence, and continued leadership in delivering life-changing diabetes care solutions.
Job Profile Name Senior Systems Engineer
Job Code EN.SYENG.SYE.P3.US1
Include Job Code in Name No
Job Profile Summary
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 · - California (san Diego - Office)