Medical Device Expert, Usability Engineering, Product Owner SCRUM (Kanban), Medical Consultant

Usability Expert IEC 62366

Risk Manager ISO 14971

SCRUM Product Owner

Clinical Consultant

A versatile, results-oriented professional with years of extensive experience in risk management, usability engineering, medical care and clinical consulting who enjoys the challenge of finding creative and resilient solutions in the highly regulated environment of medical device development. High level of technical understanding leads to his profound knowledge of the medical device being developed. Has a broad clinical background and approaches all aspects of the job with an open mind and great willingness to learn. Gladly and competently passes on acquired knowledge. Analytical thinking, sense of responsibility and initiative, coupled with own problem-solving skills and the ability to deal openly and constructively with conflicts within the team. Makes decisions or can competently contribute to them. Has a high degree of stress resistance, control ability, persuasiveness, and assertiveness.

CORE COMPETENCIES:

Quality Management, ISO 13485, Risk Management, ISO 14971, IEC 62304 & Usability Engineering, IEC 62366 & Agile Project Management & Train the trainer & Team Leadership & Solutions Advice & Communication & System Requirement Specification & Business Development