Job Detail

Hutman Diagnostics AG is a start-up, in vitro diagnostics company, developing a platform for the detection and screening of infectious diseases. We are looking for a curious, enthusiastic and motivated individual, with demonstrated success in bringing molecular diagnostic products to market.

You will manage Verification and Validation (V&V) studies, involved in the development of a molecular diagnostic system (PCR/DNA Microarray, Microfluidic cartridge and detection instrument).

To achieve this mission, you will work closely with a range of international partners and report directly to the Head of R&D.

Responsibilities:

• Take ownership and oversee the design, development, verification and validation of molecular based assays in support of pre-clinical and clinical trials.
  


• Develop and sustain the V&V skill portfolio supporting R&D strategy and business needs
  


• Create and review documents and reports, develop release testing methods and acceptance criteria, transfer new products to operations and participate in development activities necessary for world-wide regulatory clearance and launch of new products.
  


• Supervises assigned staff. Ensures that the incumbent and staff have received appropriate training and that the training is current. Provide work assignments to direct reports on a regular basis. Review and approve the work performed by other analysts. Ensure work is done in a compliant manner according to SOPs and GLP guidelines.
  


• Establish and enhance SOP, implementation and training of new procedures and processes
  


• Collaborate as necessary with other departments including project management, Quality & Regulatory Affairs and external suppliers
  


• Present scientific findings and developed technologies in meetings and publish   relevant articles in scientific journals.
  


• Willingness to travel worldwide.
  

Education and experience:

•  
  


• Several years of professional experience in the areas of product development and verification & validation of IVDs.
  


• Molecular biology background with in-depth knowledge of DNA detection methodologies.
  


• Experience leading and managing cross networked teams, is considered a strong asset.
  


• Experience in the regulated medical environment (IVDD, EN ISO 13485) and laboratory and test automation.
  


• Knowledge in Design of Experiment and applied statistics.
  


• Experience working in a start-up environment.
  


• Proactive forward thinker who leads by doing, assertive in nature with strong communication skills to match.
  


• Ability to manage and lead small teams.
  


• Excellent command of English and can write in a clear and concise fashion.
  


• Drive and passion to develop new in vitro diagnostic products that improve patients' lives.
  

If you are interested in career opportunities with Hutman Diagnostics, please send us your CV and motivation  letter to hr@hutmandiagnostics.com.