A stable startup company in the north developing an innovative medical system needs a Verification Validation Leading Engineer (Console Disposable) part of our design/improvement team.
Role Purpose:
Own hands-on execution of verification and validation activities for a combined console and disposable medical device system, ensuring timely, compliant, and traceable evidence to support FDA Pre-Submission and subsequent regulatory submissions. Supporting the Development and Clinical department tasks.
Key Responsibilities:
– Execute verification and validation testing for console hardware, software (black-box/ system level), and disposable components
– Author verification and validation protocols based on approved system and design requirements
– Develop, qualify, and maintain TEST methods, fixtures, and setups
– Execute tests, ensure data integrity, and generate clear, reviewable TEST
Role Purpose:
Own hands-on execution of verification and validation activities for a combined console and disposable medical device system, ensuring timely, compliant, and traceable evidence to support FDA Pre-Submission and subsequent regulatory submissions. Supporting the Development and Clinical department tasks.
Key Responsibilities:
– Execute verification and validation testing for console hardware, software (black-box/ system level), and disposable components
– Author verification and validation protocols based on approved system and design requirements
– Develop, qualify, and maintain TEST methods, fixtures, and setups
– Execute tests, ensure data integrity, and generate clear, reviewable TEST
Requirements:
– Degree in relevant engineering fields.
– Team member, leading/taking responsibilities
– 5+ years hands-on V V or system TEST experience in medical devices or regulated products
– Experience with design controls, TEST protocols, and reports
– Comfortable in startup environments with limited infrastructure
– Experience testing multi-disciplinary systems (HW + SW + disposables)
– Degree in relevant engineering fields.
– Team member, leading/taking responsibilities
– 5+ years hands-on V V or system TEST experience in medical devices or regulated products
– Experience with design controls, TEST protocols, and reports
– Comfortable in startup environments with limited infrastructure
– Experience testing multi-disciplinary systems (HW + SW + disposables)
This position is open to all candidates.
