Project leader System Verification
F. Hoffmann-La Roche Ltd
Rotkreuz,Zug,Switzerland,
vor 8 Tg.

Who We Are

Roche Diagnostics International Ltd in Rotkreuz is one of the world’s leading providers of diagnostic system solutions for clinics, laboratories and doctors’ offices.

The company employs over 2200 people in Rotkreuz and is one of Roche Diagnostics main sites.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity / expression, national origin / ancestry, mental / physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

The Position

As member of our Research & Development department you will help to deliver pioneering blood gas solutions, empowering health care providers to make the right decisions to save their patients’ lives.

You are responsible for testing and verification of system product specifications, e.g. analytical performance, overall system reliability and up-

time. As a project leader, you plan, budget, track and report the progress of all system verification activities. In order to guarantee a consistent testing strategy across all levels of the V-

model, you are also the coordinator of a interdisciplinary testing team which covers instrument and software tests as well as sensor and reagent tests.

Your main interfaces include the system development lead, regulatory affairs and clinical operations.

The advertised position offers :

  • Working in an interdisciplinary environment with scientists, engineers and lab specialists from various disciplines (hardware, mechanics, software, algorithms, reagents and electrochemical sensors)
  • Collaboration with colleagues from development on the definition of product requirements
  • You are the technical lead of highly skilled employees. In this capacity, you will ensure the availability of resources, materials, samples, lab infrastructure and software tools for result evaluation
  • Working in a regulated market. You will ensure that tests are executed according to international guidelines and internal processes, and you will be responsible for demonstrating substantial equivalence to predicate devices.
  • You are also part of the interdisciplinary team for regulatory submission

    Who you are

    You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies.

    Where a job title is not considered the final definition of who you are, but the starting point.

    To be successful in this role you have to :

  • Be experienced in testing, verification and specification of analytical systems comprising chemical assays. Experience in verification of hardware and software is a plus, but not mandatory.
  • Know the regulatory requirements and guidelines for verification of in-vitro-diagnostic assays. Preferably, you contributed in the past to regulatory submissions in direct contact with authorities
  • Be a people leader and a good communicator at the interfaces and with stakeholders
  • Be experienced in planning and coordination of test and verification activities
  • Preferrably be located in Rotkreuz, or willing to spend a significant portion of time in Rotkreuz
  • Roche Diagnostics International Ltd in Rotkreuz is one of the world's leading providers of diagnostic system solutions for clinics, laboratories and doctors' offices.
  • The company employs over 2200 people in Rotkreuz and is one of Roche Diagnostics' main sites. .

    Roche is an equal opportunity employer.

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