Mechanical Engineer

Job Description As a Mechanical Engineer, you will be tasked with designing both new and legacy 3D models to meet product development objectives. You will collaborate with a multidisciplinary team, including manufacturing, regulatory, and quality departments, to ensure products meet customer requirements. Your responsibilities will include applying Finite Element Analysis (FEA) to assess device risks and failure modes, preparing solid models, and designing and executing tests to verify and validate product performance, reliability, and usability. You will also be involved in technical writing to create protocols, test reports, and other documentation, as well as participating in the creation and maintenance of project-specific files. This role requires strong coordination between multiple departments such as production, sales, marketing, and product management. Hard Skills 5+ years experience as a Mechanical Engineer, with at least 2 years in the medical device industry Experience in design and development of new products within the medical device industry Experienced in using CAD software for 3D modeling and design of products Experience working with ISO and other FDA regulations in product development Experience with 3D CAD modeling software (Solidworks preferred) Proficient user of Microsoft Office applications Soft Skills Strong technical writing ability Ability to apply statistical tools for evaluation and conclusions Strong collaboration and coordination skills