Project leader System Verification

Recruiter: F. Hoffmann-La Roche AG
LocationSwitzerland (CH)
Closes: 22 Apr 2019
Ref201901-100881
Discipline: Chemistry, Regulatory Affairs, Clinical, Regulatory Affairs, Earth, Environment & Energy, Regulatory Affairs
Position Type: Permanent
Hours: Full Time

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, colour, 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 a member of our Research & Development department, you will shape the new project team for our new system development, and maintain crucial interfaces to people outside R&D (regulatory affairs, clinical operations).

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 an interdisciplinary testing team. In the project, you will report directly to the system development lead.

The advertised position offers:

  • Working in an interdisciplinary environment with scientists, engineers and lab specialists from various disciplines (algorithms, reagents and electrochemical sensors, hardware and software testing)
  • 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 establish a project team, 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 which drives 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.
  • 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
  • Your background is in Chemistry, Biology, Bio/Medical Sciences, Medicine or related fields (MSc, PhD), with professional experience in the field

Apply 

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