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Systems Architect for Medical Software Solutions

2 mesi fa


Pomezia, Lazio, Italia STERIS A tempo pieno

At STERIS, our mission is to empower our Customers to foster a healthier and safer environment through pioneering healthcare and life science solutions worldwide.

Position Overview

We are seeking a talented Software Engineer who will play a crucial role in defining the Systems and Architecture for the upcoming generation of Endoscopy reprocessing software solutions. This position involves comprehensive systems and software engineering tasks, ensuring compliance with all regulatory standards to develop intricate, innovative, and highly reliable systems that enhance the quality of life globally.

The Infection Prevention Technology (IPT) team is a forefront R&D group within STERIS, responsible for shaping and implementing technology and architectural strategies across various domains, including trace and track systems, and integration with embedded software for the management and control of interconnected medical devices.

The selected candidate will oversee the overall software systems design and architecture for complex electro-mechanical systems that include embedded firmware and connectivity for Automated Endoscope Reprocessors (AER), Drying Cabinets, Storage, and other IPT equipment within the STERIS medical device sector.

Key Responsibilities

Provide technical leadership in Systems Architecture, Software Design, Hardware interface, and Connectivity solutions for medical device software. Collaborate with upstream Marketing, Standards bodies, and Regulatory requirements to define Requirements and Design specifications. Offer in-depth technical expertise in Endoscope reprocessing technologies and Trace and Track systems, adhering to IEC and AAMI standards. Develop Architectural Designs for software creation using C++, C#, WPF & XAML, Entity Framework, with MS SQL Server integration. Lead the definition of platform software utilizing microcontrollers, Wi-Fi, Bluetooth, and RFID technologies. Create Architectural Designs and prototype models for Proof of Concept and feasibility assessments. Ensure deliverables are met in accordance with the New Product Development Phase Gate process. Formulate plans for Human Factors Engineering and Usability Testing, coordinating execution by engaging key clinical personnel from internal teams and customer sites.

Continued Responsibilities

Support Qualification Protocols Design and Test execution across all aspects of Firmware and Software, including Systems Validation. Document all facets of the software engineering processes for products, maintaining the highest quality standards in line with the QMS, cost-effectiveness, and measurable efficiency. Provide guidance and best-practice techniques to ensure compliance with all regulatory requirements. Offer technical support for software deployment at Beta sites and collaborate closely with the technical services group for troubleshooting and enhancements. Lead and guide the development and testing of prototypes, verification/validation units, and product specifications, including test development plans, test reports, and risk analysis input. Act as an effective liaison between software and hardware teams, ensuring timely completion of technical deliverables. Support Marketing initiatives for Voice of Customer and new product launches in various regions.

Educational Background

Bachelor's Degree in Engineering or Science is required.

Required Skills and Experience

A minimum of 4 years of relevant experience in software development within a Linux and/or Windows environment. Familiarity with Medical Device lifecycle development processes, particularly Medical Device Software, is advantageous. Knowledge of Design Controls, AAMI, and ISO standards is essential. Systems Engineering experience with technologies such as C++, C, C#, Entity Framework, SQL Server, Azure Dev Ops, Visual Studio, and Git is required. Comprehensive understanding and application of technical principles, theories, and concepts in the field of Medical Electrical Equipment, including methodologies for software design and development, configuration management, project scheduling, and problem resolution throughout the software development cycle.

Additional Information

STERIS is committed to equal employment opportunity and utilizes affirmative action programs to ensure that individuals are recruited, hired, trained, transferred, and promoted in all job groups without regard to race, color, religion, age, disability, national origin, citizenship status, sex, sexual orientation, gender identity, genetic information, or any other category protected by law.

STERIS is a prominent global provider of products and services that support patient care with a focus on infection prevention. We are dedicated to helping our Customers create a healthier and safer world through innovative healthcare, life sciences, and dental products and services. STERIS is a publicly traded company with a significant global presence and a commitment to equal opportunity employment.