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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

  • Be responsible for company-wide risk & usability management for technically complex medical products in the field of ophthalmology
  • Ensure compliance with requirements for risk and usability-oriented development processes
  • Control the risk management process according to EN ISO 14971 and usability of medical devices according to EN 60601-6 and EN 62366
  • Create risk management plans and planning, organization and implementation of risk analyzes in development projects
  • Assess product risks as well as coordinate, monitore and support in the implementation of risk-reducing measures
  • Create and maintain of risk and usability files according to regulatory requirements during the entire product life cycle
  • Support case management in evaluating complaints, error messages and CAPAs
  • Implement FMEAs
  • Analyze use case scenarios and requirements for user interfaces
  • Be responsible for conception, organization, implementation, evaluation and documentation 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
  • Organize and implement 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
Learn more about EPAM in Germany

Equal Employment Opportunity

EPAM Systems, Inc. is an equal opportunity employer.  We recognize the value of diversity and inclusion in creating success for our customers, business partners, shareholders, employees and communities. We are committed to recruiting, hiring, developing and promoting employees without discrimination. As a global employer, this commitment includes complying with all laws in the countries in which we operate. Nevertheless, we believe equal employment practices should not be limited to what the law requires. Equal opportunity and inclusion are essential to motivate, empower and recognize the best in everyone.

At EPAM, employment actions are based on individual qualifications, without regard to race, color, religion, creed, gender, pregnancy status, sexual orientation, gender identity, gender expression, marital or familial status, national origin, ancestry, genetics, age, disability status, veteran status, citizenship status when otherwise legally able to work, or any other characteristic protected by law.

Pay Transparency Non-Discrimination Provision

EPAM will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information. 41 CFR 60-1.35(c)

Affirmative Action Obligations as a U.S. Government Federal Contractor

As a U.S. federal government contractor, EPAM is committed to meet its affirmative action obligations to make good faith efforts to expand the recruiting pool of women, minorities, individuals with disabilities, and protected veterans through outreach, targeted recruitment, training opportunities and other activities. We affirm this commitment annually in EPAM’s Affirmative Action Plans. The full text of our Affirmative Action Plan for Persons with a Disability and Protected Veterans is available for inspection in the People Operations Department during normal business hours. Email the People Operations Department to schedule an appointment.

Accessibility for Applicants with Disabilities

EPAM is committed to working with and providing reasonable accommodation to individuals with disabilities. If you require an accommodation at any stage of the employment application process, please send an email to the People Operations Department including your name, a detailed description of your requested accommodation, and the best method to contact you. If you have already reviewed a job posting or submitted an application for a job, please include the requisition number. We will assist you and make a determination on your accommodation request on a case-by-case basis.

EEO is the Law. Applicants to and employees of EPAM Systems Inc., are protected under Federal law from discrimination.

EPAM Systems, Inc. participates in eVerify.

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