Systems Architect for Medical Software Solutions

1 settimana fa

Pomezia, Lazio, Italia STERIS A tempo pieno

At STERIS, our mission is to assist our clients in fostering a healthier and safer environment through pioneering healthcare and life science product and service solutions globally.

Position Overview

The Software Engineer we seek will play a pivotal role in shaping the Systems and Architecture for the forthcoming generation of Endoscopy reprocessing software solutions. This role encompasses a comprehensive range of 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 for individuals worldwide.

The Infection Prevention Technology (IPT) team is an advanced R&D division within STERIS, dedicated to defining and implementing technology and architectural strategies across various domains within IPT, including trace and track systems, and interfacing with embedded software for the management and control of interconnected medical devices.

The selected candidate will be accountable for delivering comprehensive software systems design and architecture across complex electro-mechanical systems, which 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 deep technical expertise in Endoscope reprocessing technologies and Trace and Track systems, adhering to IEC and AAMI standards.
  • Develop Architectural Designs for software development using C++, C#, WPF & XAML, Entity Framework, and MS SQL Server interfaces.
  • Lead platform software definition utilizing microcontrollers, Wi-Fi, Bluetooth, and RFID technologies.
  • Create Architectural Designs and prototype models for Proof of Concept and feasibility studies.
  • Ensure deliverables are met in alignment 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 groups and customer sites.

Continued Responsibilities

  • Support Qualification Protocols Design and Test execution across all aspects of Firmware and Software, including Systems Validation.
  • Document all aspects of the software engineering processes for products, ensuring the highest quality standards in accordance 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 contributions to risk analysis.
  • 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 Requirements

Bachelor's Degree in Engineering or Science.

Required Competencies

  • 4+ years of relevant experience in software development within Linux and/or Windows environments.
  • Experience in Medical Device lifecycle development processes, particularly in Medical Device Software, is advantageous.
  • Familiarity with Design Controls, AAMI, and ISO standards.
  • Systems Engineering experience with technologies such as C++, C, C#, Entity Framework, SQL Server, Azure Dev Ops, Visual Studio, and Git.
  • Comprehensive understanding and 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, and problem resolution throughout the software development cycle.

Additional Information

STERIS is dedicated 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 state or local law.

As a leading global provider of products and services that support patient care with a focus on infection prevention, STERIS is committed to creating a healthier and safer world through innovative healthcare, life sciences, and dental products and services. STERIS is a publicly traded company with a strong global presence and a dedicated workforce.

STERIS is an Equal Opportunity Employer.

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