Sr. R&D Engineer, New Products

About this opportunity

Align Technology is the industry leader and innovator in medical devices which focuses on revolutionizing the digital dental and orthodontic industry. Align Technology is looking for an Sr. R&D Engineer, New Products for our San Jose, CA office. This exciting new role would be part of a culture that is helping to improve lives every day through digital dentistry. The Sr. R&D Engineer, New Products candidate should have exceptional skills with product research and development in the medical device industry. They will be a key engineer responsible for planning, leading, and executing projects focusing on product design, testing, and process improvements. They will work closely with internal and external resources in a multidisciplinary team working with materials, software, manufacturing, and more. In this role, you will… Lead product development projects and research projects until product launch Work independently to develop and evaluate new products and solutions and adapt and improve existing ones Design and evaluate product prototypes with biomechanical test models and experimentation Design, build, and verify test hardware, software, and systems as needed Define and conduct procedures for bench top testing to evaluate product performance, including efficacy, reliability, verification, and validation Work with clinical team to conduct pilot studies and other investigations Simulate real world conditions and measure outputs using sensors Collaborate with diverse, cross-functional teams to incorporate design and features into prototypes Understand and master complex systems with sound mechanical principles Perform statistical data analysis and interpretation Perform and document work in accordance with FDA/ISO regulations, including test protocols, test results, and other requirements Communicate with professionals in the field at all levels and transition information into product improvement Conceive new product and technology ideas and patents Work in a fast-paced environment and meet critical deadlines Problem-solve issues with attention to detail Provide general engineering support in R&D In this role, you’ll need … Required Experience B.S. in Mechanical/Biomedical Engineering or other related degree with 8+ years of experience in biomedical research and/or product development M.S. in Mechanical/Biomedical Engineering or other related degree with 6-7 years of experience in biomedical research and/or product development Ph.D. in Mechanical/Biomedical Engineering or other related degree with 3-5 years of experience in biomedical research and/or product development Higher or lower years of experience will be considered for this role, potentially at a higher or lower job level Desired Experience Theoretical and experimental background in structural mechanics and/or biomechanics 3D modeling using CAD software, Solidworks preferred Test method development and validation Additive manufacturing (3D printing) for product design and development Experience in medical device industry