**What you will do:**

+ Own engineering change management, including impact assessment, documentation, approvals, and implementation across stakeholders.
+ Lead the design and development of mechanical components and systems for medical devices and execute end-to-end product development (NPD) across lifecycle phases—from concept through design, validation, and product launch.
+ Translate user and clinical needs into engineering requirements, specifications, and system-level designs and perform engineering analysis including simulations, and statistical evaluations to optimize design performance.
+ Develop and maintain technical documentation such as Design History Files (DHF), Device Master Records (DMR), drawings, labeling, and IFUs.
+ Collaborate with lab teams to plan and execute verification & validation (V&V) activities, including test method development and reporting and partner cross-functionally with R&D, Quality, Manufacturing, Regulatory, Clinical, and Ma...