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 experiencethe founders mothers nearfatal

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. Were 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 were 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 companys 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 crossfunctional 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 masters degree in computer science Mechanical Engineering Software Engineering Electrical Engineering or a related field

35 years experience in a medtech or similar field with a preference for experience in invitro 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 crossfunctional teams including product management R&D engineering quality assurance and regulatory affairs.

Well organised with an analytical mindset

Preferred qualifications:

Strong problemsolving skills to address technical challenges and optimize system performance.

Affinity with project management and the ability to prioritize tasks and meet deadlines.

Experience in a small company environment.

A passion for innovation and staying updated with emerging technologies and industry trends in in vitro diagnostics and medical devices.

Benefits

Competitive compensation and benefits package

Participation in equity options

Access to professional development opportunities for career growth and advancement including training resources.

Flexible schedule and work arrangements

Dynamic and collaborative work environment

Join us in shaping the future of healthcare where every moment is vital in the fight against bacterial infections. Were 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.