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Drive the mechanical design process, ensuring robust, reliable, and user-friendly products through partnerships. Oversee the development of devices for design verification and validation. Work closely with the development partners and manufacturers to ensure design feasibility and reliability. Provide technical expertise and mentorship for the organization. Foster a collaborative environment to promote innovation and problem-solving. Conduct feasibility assessment of different device solutions, including early prototyping, analysis, and lab testing. Execute feasibility and engineering confidence tests to determine design viability and margin. Plan the Design Outputs strategy and prepare Design Output deliverables for the DHFs following Design Controls. Support assembly process development for integrated combination products. Provide support for design verification (test method development, issue resolution). Perform root cause analysis and corrective action when required. Carry out analytical modeling of key performance attributes. Maintain comprehensive documentation of design processes, specifications, and test results. Ensure compliance with quality management systems and regulatory bodies. Work with software, electrical, and systems engineering teams, as well as quality assurance and regulatory affairs, to ensure seamless product integration. Stay abreast of industry trends, new technologies, and regulatory changes. Implement best practices for mechanical design and development. Some travel required.