Lead Engineer- System Verification

You are seeking a Lead Engineer - System Verification to join our team. In this role, you will be responsible for executing verification tests, developing test methods, analyzing measurement data, and reporting test results in compliance with international standards. Your tasks and responsibilities will include translating requirements into verification plans and protocols with a focus on traceability. You will develop reproducible and maintainable verification test methods, test set-ups, and tools. It will be your responsibility to define and document the impact on system-level behavior resulting from design changes and ensure thorough verification. You will create, implement, and enhance product test plans/protocols to ensure that product design meets specifications and quality system requirements in alignment with reference standards. Collaboration with the system team and development team to design test descriptions and acceptability criteria is essential. Familiarity with the medical device regulatory environment, including FDA regulations, MDR, and IEC standards, is required. You will conduct product tests using laboratory tools such as a multimeter and oscilloscope, performing statistical analysis of test results. Additionally, you will design test methods, conduct test method validation activities including Measurement System Analysis (MSA), and prepare relevant documentation. Providing the test area with parameters for sample testing and specifying tests to be performed will be part of your responsibilities. You will also perform and report verification and validation tests, write test reports, and create technical documentation in compliance with applicable standards and regulations. Your role will involve guiding project members in documenting development activities, coordinating the work and progress of the development team, and mentoring and supporting team members in the development of test methods and test equipment. **Work Experience:** **Skills and Qualifications:** - Bachelor's degree in Mechatronics or Electrical Engineering - 6-9 years of industry experience in a similar role with a strong understanding of the design verification process - Knowledge of international (medical) standards and regulations - Proficiency in writing and maintaining test requirements from Customer level to System Level, decomposed into subsystems, modules, software levels - Understanding of statistical methods, test method validation, and the use of MiniTAB - Broad knowledge of available market test equipment - Excellent written and spoken English skills - Quality-oriented mindset with comfort in documentation practices and understanding of objective evidence.,