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Risk and Usability Manager (m/f/d) Munich, Germany

Risk and Usability Manager (m/f/d) Description

Job #: 51516
EPAM is committed to providing our global team of 36,700+ EPAMers with inspiring careers from day one. EPAMers lead with passion and honesty and think creatively. Our people are the source of our success and we value collaboration, try to always understand our customers’ business, and strive for the highest standards of excellence. In today’s new market conditions, we continue to support operations for hundreds of clients around the world remotely, with the vast majority of our teams working from home. No matter where you are located, you’ll join a dedicated, diverse community that will help you discover your fullest potential.

DESCRIPTION



We are currently looking for a Risk and Usability Manager (m/f/d) in Munich area to make the team even stronger.

You are curious, persistent, logical and clever – a true techie at heart.

Come and join EPAM where Engineering is in our DNA.

Responsibilities

  • Responsible for company-wide risk & usability management for technically complex medical products in the field of ophthalmology
  • Ensuring compliance with requirements for 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
  • Creation of risk management plans and planning, organization and implementation of risk analyzes in development projects
  • Assessment of product risks as well as coordination, monitoring and support in the implementation of risk-reducing measures
  • Creation and maintenance of risk and usability files according to regulatory requirements during the entire product life cycle
  • Supporting case management in evaluating complaints, error messages and CAPAs
  • Implementation of FMEAs
  • Analysis of use case scenarios and requirements for user interfaces
  • Conception, organization, implementation, evaluation and documentation of formative and summative usability tests according to normative requirements
  • Process owner for SOPs risk management and usability as well as continuous improvement of the product risk management and usability process
  • Organization and implementation of internal training courses in the areas of risk management and usability

Requirements

  • Successfully completed studies in Engineering (Electrical or Mechanical Engineering, or Physics) or comparable qualifications
  • Several years of professional experience in the areas of risk management and usability engineering in medical technology
  • Sound knowledge of 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
  • Pronounced affinity for technically complex medical devices
  • Ability to moderate cross-functional teams in the context of risk management and usability engineering
  • Convincing, communicative personality with a high degree of assertiveness and organizational talent
  • Analytical, structured and solution-oriented way of working
  • Collaborative workstyle and enjoy working in multidisciplinary teams
  • Very good spoken and written English skills. German is an advantage

We offer

  • Competitive compensation depending on experience and skills
  • Regular performance assessments
  • Opportunities for personal and professional growth
  • Unlimited access to LinkedIn learning solutions
  • Friendly and enjoyable working team
  • Relocation package support
  • Regular corporate and social events
  • 30 days holiday per annum
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