Lead System Verification Engineer

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 traceability
• Developing reproducible and maintainable verification test methods, test set-ups and tools
• Defining 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 performed
• Performing and reporting of verification & validation tests
• Write test reports and other technical documentation according to applicable standards and regulations
• Guiding project members in documenting the activities of the development process
• Coordinating the work, tasks and progress of the development team
• Mentoring and supporting team members within development of tests methods and test equipment

Skills and qualifications:

• Technical Bachelors degree in e. g. Mechatronics or Electrical Engineering
• 10-12 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 Devices
• Write and maintain test requirements from Customer level to System Level, decomposed into subsystems, modules, software levels
• Understanding of statistical methods, test method validation, use of MiniTAB;
• Broad knowledge of market available test equipment
• Excellent written and spoken of English
• Quality mindset and comfortable with documentation; understands what objective evidence is.