Radisens Diagnostics is expanding its product and process development teams to extend the test menu offering on its proprietary diagnostic platform. The successful candidates will demonstrate a mix of skills, with industrial experience in a relevant product development, process development, clinical validation, or quality assurance field a distinct advantage.

Available Vacancies:

  1. Senior Development Scientists – Clinical Chemistry
  2. Senior Biomedical Engineers

 


Senior Development Scientists – Clinical Chemistry

Job Functions

  • Be a leading part of Radisens’ Assay Development team, designing, validating and implementing the next generation of integrated assay panels,
  • Drive the design and development of Radisens’ clinical chemistry assays,
  • Document research summaries and results, SOP’s and invention disclosures,
  • Follow design, verification, quality standards and best practises necessary for production test and regulatory approval,
  • Work closely with Radisens’ multidisciplinary teams in a highly innovative and interactive environment.

Required Skills and Experience

  • Ph.D. Degree in relevant discipline (Life Science/Biochemistry, or equivalent),
  • 7+ years relevant development experience, ideally within industry,
  • Proven competence in leading a Team and motivating others,
  • Strong passion for in vitro diagnostic technology,
  • Experience of several of the following is highly desirable:
    • Development of enzyme-based chemistries such as lipids, kidney function, electrolytes, liver function, etc.
    • Experience with clinical chemistry analyzers,
    • Statistical methods as they relate to clinical assays,
    • Experience with dry chemistry development,
    • Interfacing assay development with instrument design.
  • Experience with ISO requirements, GMP guidelines and regulatory approvals,
  • Experience with design control and manufacturing scale-up processes,
  • Strong analytical/problem solving skills and product development background,
  • Willingness to work in a multidisciplinary team environment,
  • Flexibility to take advantage of opportunities within a high growth company,
  • Excellent oral and written communication skills,
  • Occasional national and international travel will form part of the role,
  • Experience in Point of care test development.

Radisens Diagnostics Ltd. is an equal opportunities employer.

Candidates should apply online, using reference ASSAY-S03. Strictly no agencies.

 


Senior Biomedical Engineers

Job Functions

  • Be a leading part of Radisens’ Cartridge Development team, designing, validating and producing the next generation of integrated architectures,
  • Drive the design, development and manufacture of Radisens’ integrated test cartridges,
  • Document high-quality technical reports, SOP’s, invention disclosures and functional specifications,
  • Follow design, verification, quality standards and best practises necessary for production test and regulatory approval,
  • Work closely with Radisens’ multidisciplinary teams in a highly innovative and interactive environment,
  • Supervise and mentor junior team members,
  • Support the development of pilot production processes and manage contract manufacturers.

Required Skills and Experience

  • Primary Degree in relevant discipline (Mechanical/Biomedical, or equivalent) with 6+ years relevant industrial experience,
  • High-volume plastics/polymer mould design, part fabrication, surface modification, reagent spotting, consumable sealing/bonding, a distinct advantage,
  • Demonstrated ability to work in a multi-disciplinary and deadline-driven environment with an analytical approach to problem-solving,,
  • Strong passion for in-vitro diagnostic technology and bespoke process development,
  • Experience of several of the following is highly desirable:
    • Design-for-manufacture and high-volume consumable production,
    • Experience in an in-vitro diagnostic development and/or manufacturing environment,
    • Good experimental design, implementation and validation experience,
    • 2D CAD (e.g., AutoCAD) and 3D CAD (e.g. ProEngineer/CREO) expertise,
    • MoldFlow injection moulding software, or equivalent.
  • Experience of ISO requirements, GMP guidelines and regulatory approvals,
  • Experience with design control and manufacturing scale-up processes,
  • Strong analytical/problem solving skills, with grounding in product and/or process development,
  • Flexibility to take advantage of opportunities within a high growth company,
  • Excellent oral and written communication skills,
  • This role may require national and/or international travel.

Radisens Diagnostics Ltd. is an equal opportunities employer.

Candidates should apply online, using reference BIOMED-S03. Strictly no agencies.