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 requirements, and use-case descriptions
Contribute to system development by defining solution architecture and concept generation
Own the System Hazard Analysis and conducts safety risk assessment of issues
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
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 data related products
5+ years of experience working on APIs and cloud-based applications
3+ years hands on experience in building performance models, developing functional and non-functional requirements and supporting system integrations including grey box testing
5+ years of experience as Systems engineer in medical devices
Minimum Requirements:
Good understanding of web services, microservices, HTTP protocols, REST APIs
Familiarity with database concepts and usage
Experience working with large cross-functional teams
Exposure to data models, data driven requirements and data governance
Expertise in Systems E ngineering practices such as system architecture, requirements management, design trade-off and cost-benefit analysis, hazards and risk assessments
Expertise in concept generation, developing performance models and non-functional requirements
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.
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
Experience reviewing verification plans, protocols and reports in a regulated industry.
Familiarity with IEC 62304, ISO 14971, FDA regulations and international standards applicable to medical device software development, verification, and validation a plus.
NOTE: This position is eligible for hybrid working arrangements and requires on-site work from an Insulet office.
Additional
Additional Information
Job Summary
The Senior Systems Engineer serves as a cornerstone in enabling Insulet to translate bold product ideas into fully realized, patient-ready innovations. This role is essential to ensuring that new technologies are thoughtfully unified into cohesive solutions that meet the highest standards of safety, performance, and quality. By driving alignment across complex engineering domains during early product development, this position plays a direct role in accelerating time to market and reinforcing Insulet's ability to consistently deliver breakthrough therapies that elevate the standard of diabetes care.
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 or enhanced by the Insulet Data products group. The position will directly involve hands on concept development for features, performance models, requirements writing and risk management, grey box testing, integration plans, regulatory submissions for near real time solutions that support the Insulet Product Eco-System, and internal downstream consumers such as data analytics. Education and work experience should encompass an engineering discipline in computer science or related field and should have prior work experience in medical devices, regulatory submissions, understanding of data models and APIs, enterprise system performance and scalability.
Insulet · US