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Riskmanager Medical Device (m/w/d)

  • Location: München
  • Salary: Negotiable per year
  • Job Type:Permanent

Posted 18 Tage her

Manager / Sr. Manager Riskmanagement (m/w/d)

Based in Munich, our client is an international company involved in the development, production, and distribution of medical devices.

Our client is currently looking for a candidate for development and implementation of manufacturing processes.

If you are looking for a new challenge and are familiar within risk management, I am looking forward to our conversation.

Your tasks for this position:

  • Responsibility for the company-wide risk & usability management for technically complex medical devices in the field of ophthalmology
  • Ensuring compliance with the requirements of the risk and usability oriented development processes
  • Control of the risk management process according to EN ISO 14971 and usability of medical devices according to EN 60601-6 and EN 62366
  • Preparation of risk management plans and planning, organisation and implementation of risk analyses in development projects
  • Assessment of product risks as well as coordination, monitoring and support in the implementation of measures to reduce risks
  • Creation and maintenance of risk and usability files in accordance with regulatory requirements throughout the entire product life cycle
  • Supporting case management in the evaluation of complaints, error messages and CAPAs
  • Carrying out FMEAs
  • Analysis of use case scenarios and user interface requirements
  • Conceptual design, organisation, implementation, evaluation and documentation of formative and summative usability tests according to normative requirements
  • Continuous improvement of the product risk management and usability process
  • Organisation and implementation of internal training in the areas of risk management and usability

What is expected

  • Successfully completed degree in engineering (electrical engineering, mechanical engineering, physics) or comparable qualification
  • Several years of professional experience in the areas of risk management and usability engineering in the field of medical technology
  • Sound knowledge in the application of relevant regulations and standards (e.g. MDD, MDR, EN ISO 14971, EN ISO 13485, 21CFR820, EN 60601-6, EN 62366)
  • Knowledge of functional safety
  • Strong affinity for technically complex medical devices
  • Ability to moderate cross-functional teams in the context of risk management and usability Engineering
  • Convincing personality with strong communication skills and a high degree of assertiveness and organisational talent
  • Analytical, structured and solution-oriented approach to work
  • Collaborative work style and enjoy working in multidisciplinary teams
  • Very good knowledge of German and English, both written and spoken

Application process

  • Curriculum vitae to my e-mail:
  • Telephone call with presentation of the company
  • I am your contact person for the entire application process (interviews to contract negotiations) i.e. you do not have to apply yourself
  • Discussion of other exclusive positions that fit your profile

My contact details

I am looking forward to your application!