Senior Software Systems Engineer

December 4

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Diabetes Youth Families

WebsiteLinkedInAll Job Openings

11 - 50 employees

Founded 1938

⚕️ Healthcare Insurance

🔧 Hardware

Description

• Lead and drive the development and analysis of software requirements supporting the software development life cycle of Insulet’s innovation pipeline of wearable medical devices, including cloud and mobile applications. • Responsible for the development of software requirements by analyzing user needs and product requirements. • Create and maintain traceability matrices between requirements, design verification outputs, risk management artifacts, and software design outputs in compliance with FDA guidelines. • Generate requirement traces and reports as needed for regulatory submissions. • Manage software requirements and traceability in Insulet’s PLM and ALM tools, including version controlling of the documents. • Review and consult with Product Owners on user stories that incorporate software requirements, ensuring sufficient detail is provided to guide the Agile development teams. • Review downstream engineering teams’ development artifacts such as design/architecture documents, design failure mode analysis to ensure implementation meets the specified requirements. • Review software test deliverables such as test strategy and test cases to ensure alignment with the requirements.

Requirements

• Highly skilled in requirements writing and analysis for functional and non-functional software requirements, documentation and traceability, including system and/or software requirements, for complex systems in a multidisciplinary team environment. • Demonstrated understanding of Systems Engineering practices, such as requirements management, risk analyses, and system and/or software architecture. • Working knowledge of application lifecycle management tools (i.e. Polarion ALM, Helix ALM, Doors). • Excellent project team and collaboration skills; experience and capability working collaboratively under a Quality Management System (QMS), as part of a cross-functional team, including software developers, systems engineers, Product Owners, and design quality experts. • Contribute to continuous improvement efforts related to requirements and requirement management tools. • Experience working in Agile development environments. • Formal training in established Systems Engineering concepts. • Any Formal training or requirement development related certification. • Knowledge of diabetes management products. • Experience with Medical Device regulations (ISO 13485, ISO 14971, IEC 62304, 21 CFR part 820.30-Design Controls). • Experience with change orders within a Product Lifecycle Management (PLM) tool. • Demonstrated skills in developing and introducing innovative FDA regulated medical devices to market. • General understanding of communication, mobile technology, IoT (Internet of Things), GDPR; a strong plus. • Very detail oriented, ability to work independently with minimal supervision, self-motivated and ability to carry out impact assessment across sub systems. • Ability to effectively manage stakeholders’ expectations and drive team decisions. • Able to facilitate technical review meetings and explain content to technical and non-technical audience members including but not limited to software, analytics, Site reliability engineers, Cloud Operations, Clinical, Medical, Marketing, Data engineering, Privacy, Regulatory, Product owners, Product Managers. • Ability to communicate effectively at multiple levels of an organization and provide status reports to management. • Ability to organize and judge priorities in a dynamic environment. • Flexible to change. • Ability to build and maintain strong working relationships with colleagues in a hybrid and remote work environment with resources spread across different time zones. • Demonstrated skills with managing multiple tasks, highly adaptive mindset with ability to judge and set priorities.