7 days ago

(Senior) Design Quality Assurance Engineer - Risk Management


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(Senior) Design Quality Assurance Engineer - Risk Management

(Senior) Design Quality Assurance Engineer - Risk Management

As one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.

BIOTRONIK AG, Vascular Intervention (VI), in the Swiss town of Bülach, outside Zurich, develops and manufactures guide wires, stents and balloon catheters for the treatment of cardiovascular and endovascular diseases. The Design Assurance department combines Risk Management, Design Verification/Validation and Testing topics within the product development. These activities include knowledge transfer, planning, conduction, active participation and reviews.

For this position - (Senior) Design Quality Assurance Engineer within the Risk Management Group - we are seeking a solution-oriented and quality-conscious personality with distinct communication skills.

Your responsibilities

  • Development and establishment of methods to maintain/increase the efficiency of Risk Management within the organization
  • Lead and support of interdisciplinary teams (R&D, Production, Quality Engineering, Medical Affairs, Regulatory Affairs) in implementation of Risk
  • Management activities
  • Creation and assurance of documentation in accordance with state-of-the-art regulations and standards
  • Independent conduction of work packages, transfer of knowledge into the organization and driving of changes
  • Moderation of risk assessments; conduction of FMEAs

Your profile

  • University degree in engineering or natural sciences
  • Several years of relevant experience in the regulated industry (CE, FDA); medical devices and R&D would be highly beneficial
  • Proven track record in the successful implementation of Risk Management activities in the medical device industry (ISO 14971) and/or comparable fields
  • Knowledge in implementation of international regulations and standards in the field of vascular intervention; knowledge of combination products would be
  • advantageous
  • Knowledge of design control, requirements engineering and V&V methodology
  • Excellent moderation skills for conduction of risk assessments
  • Excellent command in spoken and written English and German

Are you interested? Please apply online via our application management system - thank you. We are looking forward to welcoming you!

Location: Bülach, Zurich | Working hours: Vollzeit  | Type of contract: Unbefristet 

Apply now under: www.biotronik.com/careers  |  Job ID: 27982 

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual
orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.