Risk Engineer Budapest

Risk Engineer
Budapest

Risk Engineer

Duties and responsibilities

Take part in risk management activities

Conduct risk analysis, define mitigating measures, evaluate risks and contribute to the creation of the risk management file of the product (according to ISO 14971)

Assist project team in evaluating system and subsystem design tradeoffs to build a reliable safety and secure critical architecture

Develop technical specification for the product including functional and non-functional attributes at the system and subsystem levels and create or maintain related Design History File (DHF) records

Work effectively with the project team and see through the implementation and the effectiveness of the defined measures

Collect, define and document risk-related requirements and user scenarios with support from technical and medical teams

Work collaboratively with the international projects teams to meet innovation and development milestones and participate in design reviews

Maintain and update requirement and verification traceability using the risk, requirement and test management tool

Evaluate risk impact of HW and SW modifications, customer complaints

Professional competencies

Relevant university degree (BSc, MSc or PhD level degree in STEM or Medical field)

Minimum 3 years of experience in safety risk management in medical device or similar safety critical industry

Passion for improving patient outcomes and customer experience

Excellent command of English language

Personal competencies

Self-motivated, fast learner enjoys working with complex systems

Innovative spirit, team player and a strong problem solver

Result-oriented and open-minded with a can-do attitude

Strong verbal and written communication skills

DESIRABLE:

Experience with risk/requirement management systems (3DExperience, Doors, Polarion, QWare)

Experience with scripting SW tools (e. g. shell scripts, Python)

Good command of German language

Hungarian language knowledge

What we offer

Become part of a corporate culture that actively promotes constructive exchanges between colleagues, customers and partners. Work with us to improve people's lives in the long term. We can offer you interesting, varied tasks and excellent opportunities for advancement, as well as an attractive salary with extensive benefits, all within a dynamic family-owned company.