Required Skills: Combination Products, Control Strategy, Design Controls, Design Failure Mode and Effect Analysis (DFMEA), Design Manufacturing, Design Verification Testing, Device Development, Drug Development, Human Factor Engineering, Immunotherapy, Mechanical Testing, Medical Device Quality Systems, Process Manufacturing, Product Risk Management, Project Leadership, Project Management, Quality Management Systems (QMS), Test Method Validation, Test Procedure Development. This role has a primary focus on design verification while encompassing the full spectrum of testing activities, including test method development and validation, analytical transfers, incoming testing, in-process, release testing, and testing readiness to enable successful clinical introduction and commercialization.