Senior Software Systems Engineer (Remote/Flexible)

Job Description

The Senior Software Systems Engineer will be leading and driving 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. 

Responsibilities  

• Responsible for the development of software requirements by analyzing user needs and product requirements.  
• Lead and drive the technical reviews of software requirements with the required stakeholders from various cross functional teams.  
• 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. 

Education and Experience 

• Bachelor of Science or equivalent degree in an Engineering (Systems, Biomedical, Electrical, Computer Science) discipline or related engineering/technical degree required. 
• Five (5) years of experience working on the technical development of medical device products. 

Required Skills and Competencies 

• 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. 

Preferred Qualifications 

• 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. 
• …