Senior Staff System Architect (Hybrid - Acton, MA.)

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.

This Senior Staff System Architect will be integral in delivering new capabilities to class II/III medical devices from concept to commercialization. The candidate must have a strong understanding of engineering and scientific fundamentals as well as end-to-end product design. This role focuses on execution of Model-Based Systems Engineering to develop and guide technical decisions for the next generation pump and ecosystem. This role will be responsible for understanding and advocating for solutions from a holistic approach. This role will require staying up to date on MBSE methodologies and technologies to support the company’s vision.

Responsibilities

• Create integrated cross-domain architecture including hardware, software, and cloud that addresses reliability, scalability, performance, and security needs 
• Perform informal and formal architectural trade off analysis for the down selection of architectural solutions 
• Design solutions for scale, resilience, and maintainability 
• Document key architectural constraints 
• Support and identify KPP/KPI’s 
• Work with cross-functional teams to develop MBSE models, prototypes, and tests 
• Present technical concepts to different audiences from executive level down to developer, to gain alignment

Required Skills and Competencies

• Highly ethical, responsible and data-driven decision-making methodology 
• Professional knowledge of medical device industry or other highly regulated industries 
• Advanced problem-solving skills to address complex architectural challenges 
• Strong communication and teamwork skills 
• System modeling methodologies such as Object-Oriented Systems Engineering Method (OOSEM)
• Systems Modeling Language (SysML)
• Model Based Systems Engineering (MBSE)
• Systems Engineering including writing requirements, performing risk assessments, and developing V&V
• Formal and informal trade study methods
• Key Performance Parameters (KPP) and Key Performance Indicators (KPI)
• Strong time management and organizational skills

Preferred Skills and Competencies

• Unified Modeling Language (UML) is a plus 
• Unified Architecture Framework (UAF) or other enterprise architecture frameworks are a plus
• Object Constraint Language (OCL) is a plus 
• ISO 14971, IEC 62304, and IEC 60601 are a plus
• Agile and Scaled Agile Framework (SAFe) are a plus
• Quality Functional Deployment (QFD) and Analytical Hierarchy Process (AHP) are a plus

Education and Experience

• Bachelor’s of Science in Biomedical Engineering, Electrical Engineering, Mechanical Engineering, Software Engineering, or Systems Engineering or related field 
• 8+ years of significant experience in applying system engineering principles and methodologies in medical device industry or other complex and regulated systems  
• 3+ years of significant experience with MBSE concepts and tools (Cameo/Catia Magic Cyber Systems Engineering/Magic Systems of Systems Architect or similar tools) 
• Significant experience leading development of SysML compliant behavioral and structural models for new features 
• Demonstratable experience in training/mentoring others in MBSE tools, methodologies, and languages
• Experience in MBSE Tool customizations and integrations is a plus 
• Experience with running simulations in (Cameo/Catia Magic Cyber Systems Engineering/Magic Systems of Systems Architect or similar tools) is a plus 
• Experience in custom profiles creation is a plus 
• Experience in MBSE Tool Model Validation Suites is a plus 
• Experience QFD and AHP are a plus

Additional Information

• The position will need to be in the Acton office at least 2x/week; may work remotely other days.
• Travel is estimated at 10-15% but will flex depending on business need.

NOTE: This position is eligible for hybrid working arrangements (requires on-site work from an Insulet office at least 1x/week; may work remotely other days). #LI-Hybrid  

Additional Information: