Required Skills: Combination Products, Component Design, Component Engineering, Controls Assurance, Design Analysis, Design Controls, Design Evaluations, Design Failure Mode and Effect Analysis (DFMEA), Design Verification, Design Verification Testing, Device Design, Engineering Leadership, Engineering Specifications, Equipment Engineering, Equipment Procurement, Human Factor Engineering, Mechanical Engineering, Mechanical Testing, Medical Device Quality Systems, Packaging Management, Process Development Engineering, Quality Management Systems (QMS), Test Method Validation, Troubleshooting. Program Delivery & Stakeholder Communication: Exceptional track record of managing complex technical milestones, balancing interdisciplinary priorities, and translating technical risks into clear, executive-level summaries for senior leadership and partner groups.