Diagnostic Test Developer

1 week geleden


Eindhoven, Noord-Brabant, Nederland ShanX Medtech BV Voltijd
Company Overview

ShanX Medtech BV is a pioneering company revolutionizing healthcare through innovative diagnostic tools. Founded on a personal mission to prevent unnecessary suffering, we're dedicated to transforming infection management with groundbreaking solutions like KAIROS IVD.

Our goal is clear: equip healthcare professionals with swift and accurate treatment decisions, combating antibiotic resistance, enhancing patient outcomes, and saving lives.

Job Description

We're seeking a motivated IVD Assay Developer to drive assay development efforts, optimize performance, and lay the groundwork for future commercialization and regulatory approval of diagnostic products.

This full-time contract spans 40 hours per week over three years, with the possibility of extension.

Responsibilities
  1. Assay Development: Craft and refine our current and future diagnostic assays to ensure optimal results.
  2. Optimization: Enhance assay performance parameters, including sensitivity, specificity, capability, and reproducibility, through iterative experimentation.
  3. Validation: Conduct validation studies to assess analytical and clinical performance of diagnostic assays using clinical samples and analyzing data to demonstrate accuracy and precision.
  4. Documentation: Thoroughly document all aspects of assay development, including experimental protocols, results, and findings.
  5. Regulatory Compliance: Ensure adherence to FDA regulations and ISO standards governing diagnostic assay development.
Requirements
  • Education: Master's degree in biology, Microbiology, Biomedical Engineering, or a related field with a preference in Biochemistry.
  • Experience: Minimally 3 years' experience in an IVD company, having developed IVD assays that received IVDR approval.
  • Skills: Past assay development according to regulatory requirements and standards relevant to the FDA regulations, ISO standards, and Good Laboratory Practices (GLP).
  • Language: Fluency in English.
  • Soft Skills: Strong analytical and problem-solving skills with attention to detail, flexibility, adaptability, and a passion for innovation.
Estimated Salary:

$120,000 - $180,000 annually, depending on qualifications and experience.

Benefits
  • Competitive Compensation: A comprehensive benefits package, including access to professional development opportunities.
  • Career Growth: Flexible schedule and work arrangements, dynamic and collaborative work environment.

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