At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.
Position Summary The Software Engineer we are looking for will be responsible for defining Systems and Architecture for the next generation of Endoscopy reprocessing software products.
The activities will encompass all aspects of systems software engineering activities, meeting all regulatory standards, to realize complex, innovative, high reliability systems that improve the quality of life of people around the world.
The Infection Prevention Technology (IPT) team is a leading-edge RD group within Steris, defining and executing on technology and architectural strategy that span a variety of domains within IPT, including trace and track systems, and interfacing with embedded software for management and control of interconnected medical devices.
He/she will be responsible for providing overall software systems design architecture across complex electro-mechanical systems with embedded firmware and connectivity for Automated Endoscope Reprocessors (AER), Drying Cabinets, Storage and other IPT equipment in Steris medical device segment.
Duties Provide technical leadership for Systems Architecture, Software Design, Hardware interface and Connectivity 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.
Education Degree Bachelor's Degree in Engineering General or Science Competencies 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.
Required Must have excellent written and verbal communication skills in the English language.
Ability to work successfully both independently and in a team environment.
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