We are looking for a Validation & Verification clinical engineer to join our team. As part of the role, you will work closely with R&D to specify, execute, and report the required tests, as well as with QA / RA to ensure that the medical QMS complies. In this role, you will play a key role in ensuring the quality and reliability of our products through rigorous testing and validation. A strong technical background, excellent problem-solving skills, and the ability to work collaboratively with various teams are required for this role.
Key Responsibilities
BSc degree in System, Mechanical, Electrical or Biomedical Engineering or related field.
Develop planning of verification activities, ensuring compliance with regulatory standards and company quality objectives.
Developing test methods for test clinical verification and validation.
Develop the test development processes including designs, reviews, implementations, and test execution.
Continuously improving testing methodology, best practices, and standards to provide consistent testing across products.
Work closely with other teams to build and maintain clinical testing.
Work collaboratively with others to drive best practices.
Requirements:
4-6 years of experience in conducting V&V activities of Medical devices, including writing, and executing test plans and protocols for medical devices with a strong emphasis on QA/RA and problem-solving.
Experience with multi-disciplinary medical device companies.
Strong technical background, and understanding of complex systems including processes.
Formal and practical knowledge of testing methodologies including design and implementation of test protocols, test harnesses tools, infrastructures, and test automation.
Excellent written and verbal communication skills.
Demonstrated knowledge of global quality and regulatory environment for medical devices including FDA CFR 21 part 820.30 and IEC 60601-1-1 (CE mark), ISO 13485, and risk management requirements and development dependencies.
Fluency in English – written and spoken.
4-6 years of experience in conducting V&V activities of Medical devices, including writing, and executing test plans and protocols for medical devices with a strong emphasis on QA/RA and problem-solving.
Experience with multi-disciplinary medical device companies.
Strong technical background, and understanding of complex systems including processes.
Formal and practical knowledge of testing methodologies including design and implementation of test protocols, test harnesses tools, infrastructures, and test automation.
Excellent written and verbal communication skills.
Demonstrated knowledge of global quality and regulatory environment for medical devices including FDA CFR 21 part 820.30 and IEC 60601-1-1 (CE mark), ISO 13485, and risk management requirements and development dependencies.
Fluency in English – written and spoken.
This position is open to all candidates.
