Lead sustaining projects from problem definition through change execution: root‑cause analysis, design updates, verification/validation, risk files, change notices and design transfer. Improve reliability, yield, and cost via data‑driven engineering (DOE, capability, SPC) and Value Improvement initiatives; convert insights into documented, audit‑ready changes. Own technical decisions for assigned materials/sub‑assemblies; collaborate with Operations, Quality, Supplier/External Ops, Regulatory and Clinical to deliver right‑first‑time outcomes. Plan and run engineering studies using state‑of‑the‑art laser test equipment; define specs, build test methods, analyze results, and present clear recommendations. In all actions, demonstrate a primary commitment to patient safety and product quality by maintaining compliance with the Quality Policy and all documented processes (e.g., design controls, risk management, test method validation, process validation). Hons Bachelor's degree in engineering (Biomedical or Mechanical preferred). 5+ years engineering experience, including 2+ years in medical device product development or sustaining. Experience with design change assessment/impact analysis for regulated products. Proven ability to lead crossfunctional teams and influence without formal authority. Working knowledge of design controls and risk management (e.g., ISO Fundamental understanding of ISO 13485 and/or 21 CFR 820 quality systems. Biomedical/anatomical understanding of urological systems. Experience in polymer‑based medical devices (silicone preferred). Experience with PLM systems (e.g., Windchill) and technical project management.