Medical Product Design and Documentation

You should have a Bachelor's or Master's degree in Mechanical Engineering with 5 to 7 years of overall work experience, including 3 to 5 years in the medical device industry. Proficiency in CAD software like Solid Edge and NX, as well as in engineering calculations, is essential. Additionally, you should have a strong understanding of GD&T and tolerance stack-up analysis. As a Mechanical Engineer, you will be responsible for generating alternative mechanisms, concepts, and solutions for problems or processes, focusing on design for technical cost reductions. You should also be able to perform theoretical calculations for the concepts you develop. Utilizing existing tools and methodologies, you will report and track product, project, and process metrics. Experience in design control process, DHF documentation, and remediation for medical devices is required. Familiarity with EU MDD to MDR transition, conducting gap analyses, and risk management and analysis (such as FMEA and failure analysis) is preferred. Knowledge of Polarion software is also desirable for this role.,