Job Requirements

We are looking for Lead Engineer- System Verification. In this role you will, take ownership of the execution of verification tests, develop test methods, analyze measurement data and report test results in accordance with internationally established standards. 

Tasks and responsibilities:

Translating requirements into verification plans and protocols while ensuring traceabilityDeveloping reproducible and maintainable verification test methods, test set-ups and toolsDefining and documenting the impact on system level behavior as a result of design changes, and ensuring this is fully verified.Create, implement and develop the product test plans/protocols and generate test reports to ensure product design meets the specifications and quality system requirements also in accordance to the references standards.Work closely with system team and developing team to design test descriptions and acceptability criteria.Familiarity with medical device regulatory environment including FDA regulations, MDR and IEC standards.Perform product tests using laboratory tools (multimeter, oscilloscope, etc.).Perform statistical analysis of test results.Design test methods and perform test method validation activity, including MSA, writing the relative documentation.Provide test area with parameters for sample testing and specifies tests to be performedPerforming and reporting of verification & validation testsWrite test reports and other technical documentation according to applicable standards and regulationsGuiding project members in documenting the activities of the development processCoordinating the work, tasks and progress of the development teamMentoring and supporting team members within development of tests methods and test equipment

 

 

 

 

Work Experience

 

Skills and qualifications:

Technical Bachelor's degree in e.g. Mechatronics or Electrical Engineering10-12 years of industry experience in a comparable area of responsibility including solid understanding of design verification process.Knowledge of international (medical) standards and regulations.Knowledge and experience with standards in Medical DevicesWrite and maintain test requirements from Customer level to System Level, decomposed into subsystems, modules, software levelsUnderstanding of statistical methods, test method validation, use of MiniTAB;Broad knowledge of market available test equipmentExcellent written and spoken of EnglishQuality mindset and comfortable with documentation; understands what objective evidence is.