Plan, execute, and document verification and validation activities for medical devices throughout the product lifecycle
Develop and review test protocols, test plans, and validation reports in compliance with regulatory standards such as MDR, ISO 13485, and IEC 60601
Perform risk assessments related to verification and validation processes
Collaborate with R&D, Quality Assurance, Regulatory Affairs, and Manufacturing teams to ensure product compliance and quality
Utilize tools such as TestStand, LabVIEW, or similar for automated testing and data acquisition
Manage and maintain test equipment and validation environments
Analyze test data, identify issues, and implement corrective actions
Continuously improve verification and validation processes to increase efficiency and effectiveness
WYMAGANIA:
Bachelor’s or Master’s degree in Engineering, Medical Technology, or a related field
Proven experience in verification and validation in a regulated environment
Knowledge of regulatory standards such as MDR, ISO 13485, IEC 60601, and risk management principles is a plus
Hands-on experience with testing tools and software such as TestStand, LabVIEW, or equivalent
Familiarity with statistical analysis tools and data analysis software
Excellent problem-solving, organizational, and communication skills
Ability to work independently and collaboratively in a multidisciplinary team
OFERUJEMY:
A great job opportunity in an international fast growing business as a leader in Surgical tables, Hospital Beds, Surgical Equipment and Patient Positioning Accessoires within the Reinsberg Group
Talent development, professional certification opportunities, continuous learning as well as internal and external training opportunities
An exiting position reporting directly to the R&D Management
A collaborative and dynamic work environment with a high skilled and passionate team
Competitive salary packages with flexible working hours