- M.S., Mechanical Engineering, Pennsylvania State University, 2010
- B.S., Summa Cum Laude, Mechanical Engineering, Lafayette College, 2008
- Professional Engineer Mechanical, California, #39657
- Professional Engineer, Pennsylvania, #PE084451
- Tau Beta Pi
- Sigma Xi
- American Society of Mechanical Engineers—ASME
- American Society for Testing and Materials—ASTM
Mr. Rau uses mechanical engineering principles and applies advanced technical tools to solve complex problems related to drug delivery systems, combination products, medical devices, consumer products, and consumer electronics. Using his knowledge of solid mechanics and material behavior, he provides consulting support for functional evaluations, failure analyses, as well as verification and validation activities for products, computational models, and test methods.
Mr. Rau has evaluated a variety of combination and drug delivery products, including drug eluting stents, on-body delivery systems (OBDS), prefilled syringes, ocular drug delivery and surgical systems, and hormonal contraceptive delivery devices. He assists clients by developing methods, justifications, and strategies for evaluating the performance of combination products, especially when standardized approaches are not well established. Mr. Rau has prepared technical materials for combination products for use in regulatory submissions.
Mr. Rau has extensive experience conducting and overseeing custom mechanical testing programs for a variety of products. He is proficient in the operation of mechanical load frames and specializes in the design of custom fixturing to meet unique client needs. Mr. Rau has performed standard and non-standard material tests on a variety of engineering and biomaterials, including biological tissues, Nitinol, ultra-high molecular weight polyethylene (UHMWPE), and polyetheretherkeytone (PEEK). He is familiar with industry standards pertaining to the evaluation of medical devices, combination products, and biomaterials, including regulatory requirements and quality assurance procedures.
Mr. Rau has been active for over a decade in the development of guidance documents related to best practices for verification and validation ("V&V") used in computational modeling of medical devices. He serves on the ASME Codes and Standards subcommittee: ASME V&V 40 Subcommittee on Verification and Validation in Computational Modeling of Medical Devices.