• Lead and contribute to the end-to-end product development lifecycle, from concept and feasibility to design transfer and commercialization. • Develop 3D models, detailed drawings, and engineering documentation using CAD software (e.g., SolidWorks, Creo) to support mechanical and electromechanical device design. • Conduct design verification and validation (V&V) testing, analyze data, and generate technical reports that demonstrate compliance with applicable standards and requirements. • Collaborate with Quality, Regulatory, Manufacturing, and Clinical teams to ensure design activities align with Design Control (21 CFR 820.30) and risk management standards (ISO 14971). • Participate in risk analyses (FMEA, DFMEA, PFMEA), hazard assessments, and mitigation strategies throughout the product lifecycle. • Support prototype fabrication, bench testing, and design iteration, translating test results into actionable design improvements. • Work with Manufacturing Engineering to ensure Design for Manufacturability (DFM), Design for Assembly (DFA), and process validation (IQ/OQ/PQ) readiness. • Prepare and maintain Design History File (DHF) documentation and ensure compliance with ISO 13485 quality system requirements. • Support the design transfer process, including pilot builds, process validations, and technical documentation for production release. • Contribute to continuous improvement initiatives, applying statistical methods, Lean, and Six Sigma principles to enhance design efficiency and product quality.