System Architect

ShanX Medtech BV (SXM, NL) is a dynamic young company dedicated to

revolutionizing healthcare through innovative diagnostic tools. Our journey

began with a deeply personal experience—the founder's mother's near-fatal

struggle with a poorly treated bacterial infection. This ignited our mission to

transform infection management, propelling us to develop pioneering solutions

that prevent unnecessary suffering.

At SXM, impact is paramount. We're proud to introduce KAIROS IVD, our

groundbreaking rapid antibiotic susceptibility testing device, poised to redefine

how bacterial infections are treated. Our goal is clear : to equip healthcare

professionals with the means to make informed treatment decisions swiftly and

accurately. Through our innovative solutions, we're combating antibiotic

resistance, enhancing patient outcomes, and saving lives.

As a system architect at SXM you will be responsible for designing the blueprint

of the KAIROS systems, ensuring they meet the requirements of stakeholders,

regulatory standards, and industry best practices while driving innovation and

advancing the company's mission in improving healthcare outcomes.

Tasks

Your responsibilities include but are not limited to :

System Requirements & architecture : Ownership of the system requirements and translating user requirements to device input Defining the overall architecture of the full KAIROS systems, including hardware, software, interfaces, connectivity and data (analysis) components.

System Design & Integration : Ensuring seamless integration of various subsystems, modules, and components to create a cohesive and efficient diagnostic platform.

Performance Optimization : Identifying opportunities to enhance system performance, scalability, reliability, and efficiency through architectural improvements.

Risk Management : Assessing safety hazards and mitigating technical risks associated with system use and architecture, ensuring compliance with regulatory standards and quality requirements.

Collaboration : Working closely with cross-functional teams at development partners including product management, R&D, engineering, manufacturing, quality assurance, and regulatory affairs to ensure alignment and successful implementation of system architecture.

Documentation : Documenting system requirements, architecture design, risk management, specifications, and technical decisions to facilitate communication and knowledge transfer within the organization.

Continuous Improvement : Participating in continuous improvement efforts to enhance the overall quality, functionality, and performance of diagnostic systems.

Requirements

Required qualifications :

• PhD or master’s degree in computer science, Mechanical Engineering, Software Engineering, Electrical Engineering, or a related field
• 3-5 years’ experience in a medtech or similar field, with a preference for experience in in-vitro diagnostic development
• Technical skills such as proficiency in system architecture design, including hardware, software, and data components.
• Strong understanding of diagnostic system requirements, including regulatory and quality standards (FDA & ISO).
• Understanding of regulatory requirements and experience in designing systems compliant with FDA and / or CE regulations.
• Experience with diagnostic instrumentation and / or medical device development.
• Knowledge of relevant programming languages, such as C++, Java, or Python.
• Familiarity with software development methodologies, such as Scaled Agile or Scrum.
• Excellent writing and communication skills to collaborate effectively with cross-functional teams, including product management, R&D, engineering, quality assurance, and regulatory affairs.
• Well organised with an analytical mindset

Preferred qualifications :

Benefits

Join us in shaping the future of healthcare, where every moment is vital in the fight against bacterial infections. We're seeking a motivated System Architect to join our team and contribute to the development of this crucial diagnostic device.

This is an exceptional opportunity to join us in our early stages and play a pivotal role in our future success.