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