Informacje o stanowisku

Responsibilities:

• Participation and be an active part in our R&D projects of new medical devices, especially in testing and documentation
• Play an important role in our Product Management of new and released products with-in end user evaluation, implementing and identifying new Rage Care activities
• Leading role in activities like usability, design validation
• Involved in problem solving activities, root cause analysis and support Complaints if R&D engineering is required
• Work in line with Quality Management System procedures and international standards and regulations, relevant for Medical Devices (like ISO 13485, FDA 21 CFR 820.30, MDD 93/42/EEC, MDR 2017/745, ISO 14971)
• Analyzing state of the art for similar products and defining input requirements for projects, in line with relevant safety product standards (like IEC 60601-1, ISO 10993)
• Lead and participation in designing and executing pre-clinical tests
• Support preparation of technical documentation related to design and development, testing, and other regulatory purposes
• Cooperation with project teams, clinical experts, regulatory officers, technical consultants, End users, Distributors and End-users
• Reporting to BU Director and project manager

Requirements:

• Minimum 2-years of experience in similar position and ideally in Medical Device Industry
• Knowledge of relevant industry standards (like ISO 13485, ISO 14971, IEC 60601-1, IEC 62366, ISO 11607, ISO 10993) will be advantage
• Experience with metrological and laboratory equipment. Willingness to work “hands on” with device
• Ability to work in a Team and prioritize own workload

We offer:

• Working in the R&D department in an international, interdisciplinary team
• Great atmosphere in the office and interesting challenges
• Opportunity to grow with the organization and build a successful career path
• A number of benefits (private medical care, sports card, flexible working time, English lessons)

Poznań - Oferty pracy w okolicznych lokalizacjach