• Assist with developing and evaluating product designs through Design Verification & Validation testing and First-In-Human Clinical Study in full compliance with the company’s Design Control requirements in a QMS environment and consistent with FDA, ISO, and MDR requirements.• Conduct hands-on work and rapid prototyping to support device, test, and process development.• Prepare technical documentation, including test methods, protocols, engineering reports, and manufacturing work instructions to support design control activities and regulatory submissions.• Perform product design verification and validation testing• Identify suppliers and maintain relationships to ensure the delivery of superior components and services • Responsible for component and assembly documentation for new products being developed • Represent R&D on manufacturing-related project activities, including internal and external requests. • Analyzes, evaluates, sources, and coordinates the procurement of new materials to support R&D, rapid prototyping, and ongoing clinical study • Work collaboratively in a cross-functional team to periodically update operations, quality, regulatory, and clinical affairs regarding project status.• Interact with physicians regarding product development, testing, and product demonstrations.

• Responsible for designing product features and fixtures to support R&D activities, design verification processes, clinical studies, and corrective actions.• Trained on usage of quality management system and documentation of medical device design and development activities in compliance with ISO 13485:2016• Generated engineering requirements for implant tools according to user and market needs as outlined in the design matrix for the PSCA Implant system• Familiar with generating purchase orders and working with vendors to receive clinical and R&D materials with corresponding certificates as needed by internal inspection requirements• Experienced with materials inspection and collation of appropriate documentation and certifications for storage within quality management system

• Responsible for system integration, functionality, and implementation of the suspension subsystem on the 2022-2023 chassis• Developed fixtures to locate chassis tubing and control arms for GTAW processes• Designed rear wheel spindles and rockers for 2022-2023 outboard suspension• Conducted finite element analysis on wheel spindles and rear rocker arms to identify stress concentrations and FOS under expected suspension load conditions• Utilized Lotus Shark to identify maximum CV articulation and turn radius of the 2022-2023 suspension• Created custom front & rear templates to simulate rocker arm suspension in Lotus Shark