Align Technology is the industry leader and innovator in medical devices, focusing on revolutionizing the digital dental and orthodontic industry. We are seeking a Sr. R&D Engineer, Core Product for our San Jose, CA office. This role involves contributing to digital dentistry innovations that improve lives daily. The Sr. R&D Engineer, Core Product will be responsible for leading product research and development projects, focusing on product design and improvement. The ideal candidate should have expertise in medical device product development and mechanical design, working closely with multidisciplinary teams involving materials, software, and manufacturing to enhance product performance and design. Role responsibilities include: Leading multiple product development and research projects from conception to launch Developing and evaluating new products and solutions independently Designing and testing prototypes, providing technical analysis and recommendations Building and verifying test hardware, software, and systems Conducting bench top testing for efficacy, reliability, verification, and validation Collaborating with clinical teams on pilot studies and investigations Simulating real-world conditions and measuring outputs with sensors Working with cross-functional teams to incorporate design features into prototypes Understanding complex systems with sound mechanical principles Performing statistical data analysis and interpretation Ensuring compliance with FDA/ISO regulations in testing documentation Creating product and test plans in collaboration with team members Communicating with professionals across the field to inform product improvements Conceiving new product and technology development plans Working efficiently in a fast-paced environment to meet deadlines Mentoring peers and junior engineers, providing leadership Providing general engineering support in R&D Qualifications: B.S. in Mechanical/Biomedical Engineering or related field with 8+ years of experience, or M.S. with 6-7 years, or Ph.D. with 3-5 years in biomedical research or product development Strong background in structural mechanics and biomechanics Experience with additive manufacturing, rapid prototyping, CAD software (SolidWorks), scripting/programming, and finite element analysis Experience in the medical device industry, especially in orthodontics or dental fields Pay transparency details are provided regarding salary ranges, which depend on experience, location, and other factors. Compensation includes base salary, potential incentives, and geographic adjustments where applicable.

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