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(Senior) Design Assurance Engineer - Risk Management

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(Senior) Design Assurance Engineer - Risk Management


(Senior) Design 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.


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 Assurance Engineer within the Risk Management Group - we are seeking for a solution-oriented, responsible 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
  • Ideally, 7+ 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 through our application management system - thank you. We are looking forward to welcoming you!


Location: Buelach, ZH | Working hours: Vollzeit  | Type of contract: Unbefristet 

Apply now under: www.biotronik.com/careers

Job ID: 27982  | Contact: Patrick Weymann  | Tel. +41 44 864 5347 


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.


No unsolicited agency referrals please. We are not responsible for any fees related to unsolicited resumes from recruitment agencies - Only direct applications will be considered for this position opening.


Bülach, CH-ZH / Bülach ZH / Bülach / Zurich, CH-ZH / Zürich, CH-ZH / Buelach, CH-ZH

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