Independently develop and maintain mechanical engineering documentation throughout the product lifecycle, including design specifications, drawings, engineering analyses, design reviews, change orders, and Design History File (DHF) records, in accordance with established design controls, FDA requirements, and applicable quality system procedures. Collaborate with Quality Assurance, Regulatory Affairs, Manufacturing, suppliers, and other cross-functional teams to ensure mechanical designs and supporting documentation meet applicable regulatory and quality requirements and support regulatory submissions, including 510(k) submissions where applicable.