Technical Leader Regulatory Verification

Job Responsibilities 1) Main tasks: Tasks performed regularly which form the essential characteristics of the position, • Organization and execution of product verification of medical products, accessories and modules. • Ensure that product requirements are testable • Definition and coordination of test strategies • Planning and organization of the system verification incl. Coordination with other departments, projects and external labs • Planning and organization of necessary resources • Creation of test specifications, test cases and test activities • Definition and creation of test set-ups • Familiar with various testing equipment to perform defined testing. • Execution of system verification to ensure that the design input has been achieved • Identification, analysis and documentation of deviations • Creation of associated verification documents acc. to internal and external requirements • Ensure that such documentation is audit-proof • Coordination of necessary verification measures in the design change process • Play the role of an independent reviewer for high level design reviews 2) Secondary tasks: Tasks performed regularly in addition to the main duties but which do not determine the essential character of the position. • Consultant in regard of internal and external standards requirements • Risk management • Internal and external requirements (such as IEC 60601-1, IEC 60601-1-2, IEC 60601-2-16 etc.) • Coordination of regulatory approval activities • Quality assurance for approval submission documentation • Organize and draft approval submission documentation • Strong technical support to the Team, Method and Lab Running • Be a professional at samples preparing, operating, debugging & simulating according to the project needs 3) Miscellaneous tasks: Tasks not performed regularly which are nevertheless a distinct part of the job, or special tasks / project work. • Other tasks assigned by superior leader Qualifications, experience, know-how and skills critical for success* 1) Required training and education: • BS or MS in EE/ME/BM Engineering or related filed 2) Required professional experience (in years): Please list the minimum number of years of professional experience required, as well as all relevant experience in specific functions, e.g. project management or line management experience. • Verification Engineer--Minimum 3 years in Medical R&D related area (Prefer HD area) • Sr. Verification Engineer--Minimum 5 years in Medical R&D related area (Prefer HD area) • Technical Leader--Minimum 8 ears in Medical R&D related area (Prefer HD area) 3) Important personal qualities: Please list the qualities that are of special significance for the successful performance of tasks if they have not been outlined sufficiently in a attached competence profile. • Ownership & Responsibility • Hard working, focusing on Quality & Details. • Team player, good communicator 4) Other specialized knowledge: a) Technical knowledge • Familiar with QMS related standard (ISO 9001, ISO 13485 etc.) b) Languages • Strong English verbal and written communication skills. c) IT skills • Have excellent skills with general computer use and office applications such as Microsoft Word, Excel, and Power point. d) Product knowledge • Familiar with medical device industry and knowledge of HD dialysis machine preferred 5) Special personal requirements: Please list requirements such as willingness to travel or work weekends or shifts etc. • Willingness to travel if business required and • Be comfortable working in a global organization • Be comfortable working under pressure