IVD Assay Developer

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 an IVD Assay Developer at SXM you will be responsible for the development and optimization of our diagnostic assays for future commercialization. The role of the IVD Assay Developer is crucial in driving assay development efforts optimizing assay performance and laying the groundwork for future commercialization and regulatory approval of diagnostic products.

This is a fulltime contract for 40 hours per week extending over three years with the possibility of extension.

Tasks

Your responsibilities include but are not limited to:

Assay Development: Crafting and refining our current and future diagnostic

assays.

Optimization: Enhancing assay performance parameters such as sensitivity

specificity capability and reproducibility through iterative experimentation. This

includes identifying and refining assay protocols and formulations to achieve

optimal results.

Validation: Conducting validation studies to assess the analytical and clinical

performance of diagnostic assays. This involves testing assay performance with

clinical samples and analyzing data to demonstrate accuracy and precision.

Documentation: Thoroughly documenting all aspects of assay development

including experimental protocols results and findings. This meticulous recordkeeping

will be used for regulatory submissions and intellectual property

protection.

Regulatory Compliance: Ensuring adherence to regulatory requirements

governing diagnostic assay development. This includes compliance with FDA

regulations and ISO standards.

Quality Assurance: Implementing quality control measures to uphold the

reliability and consistency of our diagnostic assays. Adherence to standard

operating procedures and quality management systems ensures highquality

standards are maintained.

Requirements

• Required qualifications:

Masters degree in biology Microbiology Biomedical Engineering or a related field with a preference in Biochemistry.

Minimally 3 years experience in a relevant position in an IVD company having developed IVD assays that received IVDR approval.

Past assay development according to regulatory requirements and standards relevant to the FDA regulations ISO standards and Good Laboratory Practices (GLP). Ability to work according to quality management systems.

Fluency in English.

Strong analytical and problemsolving skills with attention to detail.

• Preferred qualifications:

Flexibility and adaptability to work in a dynamic and fastpaced environment with evolving priorities and timelines.

A passion for innovation and a creative outofthebox mindset are highly valued.

Passionate about working in a young IVD company.

Commitment to continuous learning and professional development to enhance skills and knowledge in assay development rapid Antibiotic Susceptibility Testing (AST)

diagnostics and related areas.

Benefits

Competitive compensation and benefits package

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 IVD Assay Developer 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.