Hardware Verification Engineer
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What you'll do
- 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 especially in mechanical profession.
- Definition and creation of test set-ups, test tool and fixture development as required.
- Familiar with various testing equipment (such as micro-meter, pressure-meter, temperature-meter, force-gauge, coordinate measuring machine, material tension test machine etc.) 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.
What they're looking for
- BS or MS in Mechanical Engineering 'automation Engineering or related filed
- Sr. Verification Engineer--Minimum 5 ears in Medical R&D related area (Prefer HD area)
Nice to have
- Prefer HD area
- Experience in mechanical design and manufacture process is preferred.
- Familiar with medical device industry and knowledge of HD dialysis machine is preferred.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
Job Responsibilities
1) Main tasks:
• 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 especially in mechanical profession.
• Definition and creation of test set-ups, test tool and fixture development as required.
• Familiar with various testing equipment (such as micro-meter, pressure-meter, temperature-meter, force-gauge, coordinate measuring machine, material tension test machine etc.) 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.
• Acting as a "Leader Verification" for development projects (Sr. Verification Engineer).
• Play the role of an independent reviewer for hi h level desi n reviews
2) Secondary tasks:
• Consultant in regard of internal and external mechanical standards requirements
• Creation of approval submission documentation.
• Quality assurance for approval submission documentation
• Organize and draft approval submission documentation.
• Strong technical support to the Team, Method and Lab Running
• Be a Coach for R&D internal employees for product (HD etc.) technical Introduction & Training (Sr. Verification Engineer)
• Be a professional at samples preparing, operation debugging & simulating according to the project needs
Qualifications, experience, know-how and skills critical for success*
1) Required training and education:
• BS or MS in Mechanical Engineering 'automation Engineering or related filed
2) Required professional experience (in years):
• Sr. Verification Engineer--Minimum 5 ears in Medical R&D related area (Prefer HD area)
3) Important personal qualities:
• Ownership & Responsibility
• Hard working, focusing on Quality & Details.
• Team la er, good communicator
4) Other specialized knowledge:
a) Technical knowledge
• Familiar with QMS related standard (ISO 9001, ISO 13485 etc.)
• Familiar with Medical Device safety standard (IEC60601-1, GBfT9706.1, GBfT14710, etc.)
• Familiar with mechanical design software, like auto CAD, Creo, Solidworks, UG..
• Experience in mechanical design and manufacture process is preferred.
• Experience in material test such as MSDF, UL94 test, UV Test.
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 is preferred.
5) Special personal requirements:
• Willingness to travel if business required and
• Be comfortable working in a global organization
• Be comfortable working under pressure
Company
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