(Senior) Deployment Engineer overseeing the installation and commissioning of complex systems. Working for PLATH GmbH in international project environments to ensure stable operations.
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Hybrid Senior Systems Engineer, Caregiver Solution
Posted 3 months ago
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
Requirements
- 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
Benefits
- Medical, dental, and vision insurance
- 401(k) with company match
- Paid time off (PTO)
- And additional employee wellness programs
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