Software Architect

At Steris, we are seeking a highly skilled Software Engineer to join our Infection Prevention Technology (IPT) team. As a key member of our team, you will be responsible for designing and developing software systems for our next-generation Endoscopy reprocessing products.

• Provide technical leadership for Systems Architecture, Software Design, and Hardware interface solutions for medical device software.
• Define Requirements and Design specifications in collaboration with upstream Marketing, Standards bodies, and Regulatory requirements.
• Provide deep technical expertise in Endoscope reprocessing technologies and Trace and Track systems, in accordance with IEC and AAMI standards.
• Create Architectural Design for developing software in C++, C#, WPF XAML, Entity Framework, with MS SQL Server interface.
• Lead platform software definition with microcontrollers, Wi-Fi, Bluetooth, and RFID technologies.
• Create Architectural Designs and prototype models for Proof of Concept and feasibility.
• Execute on meeting deliverables in accordance with New Product Development Phase Gate process.
• Develop plans for Human Factors Engineering and Usability Testing and coordinate execution by identifying and engaging key clinical personnel from internal groups and customer sites.
• Give support to Qualification Protocols Design and Test execution across all aspects of Firmware and Software, including over Systems Validation.
• Create and document all aspects of the software engineering processes for products, incorporating the highest quality standards in accordance with the QMS, cost effectiveness, and measurable efficiency.
• Provide guidance and best-practice techniques to meet all regulatory compliance requirements.
• Provide technical support for software deployment at Beta sites and work closely with technical services group for troubleshooting and making enhancements.
• Lead and provide guidance in the development testing of prototypes, verification/validation units, and product specifications, including test development plans, test reports, and input to risk analysis.
• Provide an effective bridge between software and hardware personnel and be responsible for the timely completion of the technical deliverables.
• Provide support to Marketing for Voice of Customer and new product launches in US and Europe.

Requirements:

• 4+ years related experience in software development in a Linux and/or Windows environment.
• Experience in Medical Device lifecycle development processes, particularly Medical Device SW, will be a plus.
• Familiar with Design Controls, AAMI, and ISO standards.
• Systems Engineering experience for designing with technologies – C++, C, C#, Entity Framework, SQL Server, Azure Dev Ops, Visual Studio Git.
• Complete understanding and wide application of technical principles, theories, and concepts in the field of Medical Electrical Equipment, including tools and methodologies for software design and development, configuration management, project scheduling, problem resolution for the complete software development cycle.
• Excellent written and verbal communication skills in the English language.
• Ability to work successfully both independently and in a team environment.