Sr. R&D Engineer, Core Product

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Department: Research & Development

Location: US-California-San Jose

Compensation: $135,200 - $185,900 / year

Position: Sr. R&D Engineer, Core Product

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 role 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

• 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 different level in the same job family
• Theoretical and experimental background in structural mechanics and/or biomechanics
• Experience with additive manufacturing and rapid prototyping processes for product design and development
• Experience with 3D modeling using CAD software, Solidworks preferred
• Experience with scripting/programming
• Experience with finite element analysis
• Experience in medical device industry
• Experience in orthodontics and/or dental…