R&D Engineer III, Core Product

Align Technology-posted 3 months ago

Senior

San Jose, CA

5,001-10,000 employees

Miscellaneous Manufacturing

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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 a Sr. R&D Engineer, Core Product 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, Core Product candidate should have exceptional skills with product research and development in the medical device industry. The Sr. R&D Engineer, Core Product will be the lead engineer responsible for planning, leading, and executing projects focusing on product design and design improvement. This person is seen as a subject matter expert in the medical device product development and mechanical design related fields. They will work closely with internal and external resources in a multidisciplinary team working with materials, software, and manufacturing to conduct research and development in the areas of product performance, design, and improvement. This role will be part of Align Technology's goal to deliver our clear aligners (Invisalign) to our customers.

Lead multiple 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, while providing in-depth technical analysis and design recommendations for business sensitive solutions
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
Exercise independent judgment of and define methods, techniques, and evaluation criteria to assess product performance and conduct bench top testing
Responsible for ensuring that testing covers efficacy, reliability, verification, and validation
Perform statistical data analysis and interpretation
Perform and document work in accordance with FDA/ISO regulations, including test protocols, test results, and other requirements
Collaborate with manager and cross-functional team in creating product and test plans
Network and communicate with professionals in the field at all levels and transition information into product improvement
Conceive new product and technology development plans
Work in a fast-paced environment and meet critical deadlines
Problem solve issues with attention to detail
Actively coach, motivate, mentor and provide leadership to peers and Jr. engineers
Provide general engineering support in R&D

Exceptional skills with product research and development in the medical device industry
Experience in product design and design improvement
Strong knowledge in mechanical design related fields
Ability to work closely with internal and external resources in a multidisciplinary team
Experience with materials, software, and manufacturing in product development
Ability to conduct research and development in product performance, design, and improvement
Strong problem-solving skills with attention to detail
Ability to perform statistical data analysis and interpretation
Familiarity with FDA/ISO regulations

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