Diagnostic Assay Development Specialist

3 dagen geleden


Eindhoven, Noord-Brabant, Nederland ShanX Medtech BV Voltijd
About ShanX Medtech BV

ShanX Medtech BV is a rapidly growing young company dedicated to revolutionizing healthcare through cutting-edge diagnostic tools. Founded on the principle of transforming infection management, our mission is to equip healthcare professionals with innovative solutions that prevent unnecessary suffering.

We're proud to introduce KAIROS IVD, our groundbreaking rapid antibiotic susceptibility testing device poised to redefine how bacterial infections are treated. Our ultimate goal is to combat antibiotic resistance, enhance patient outcomes, and save lives.

Job Title: Diagnostic Assay Development Specialist

We're seeking a highly motivated and experienced Diagnostic Assay Development Specialist 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.

Job Description:

The Diagnostic Assay Development Specialist will be responsible for developing and optimizing our diagnostic assays for future commercialization. The role is crucial in driving assay development efforts, optimizing assay performance, and laying the groundwork for regulatory approval of diagnostic products.

Key Responsibilities:
  • Assay Development: Crafting and refining current and future diagnostic assays.
  • Optimization: Enhancing assay performance parameters such as sensitivity, specificity, capability, and reproducibility through iterative experimentation.
  • Validation: Conducting validation studies to assess analytical and clinical performance of diagnostic assays.
  • Documentation: Thoroughly documenting all aspects of assay development, including experimental protocols, results, and findings.
  • Regulatory Compliance: Ensuring adherence to regulatory requirements governing diagnostic assay development.
Requirements:
  • Education: Master's degree in biology, Microbiology, Biomedical Engineering, or a related field.
  • Experience: Minimally 3 years' experience in a relevant position in an IVD company, having developed IVD assays that received IVDR approval.
  • Skills: Past assay development according to regulatory requirements and standards relevant to FDA regulations, ISO standards, and Good Laboratory Practices (GLP).
Benefits:
  • Competitive Salary: $120,000 - $150,000 per year based on experience.
  • Professional Development Opportunities: Access to training resources and opportunities for career growth and advancement.
  • Flexible Work Arrangements: Flexible schedule and work arrangements.
  • Collaborative Work Environment: Dynamic and collaborative work environment.

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