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 R&D Engineer III in the New Applications - Product Research Engineering group at the Morrisville, NC office. This exciting new role would be part of a culture that is helping to improve lives every day through digital dentistry.

The R&D Engineer III candidate should have exceptional skills with product research and development in the medical device industry. The R&D Engineer III will be the lead engineer responsible for planning, leading, and executing projects focusing on product design and design improvement. 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.

Role expectations

• 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

• Collaborate with diverse, cross-functional teams to incorporate design and features into prototypes and develop new manufacturing processes

• Coordinate with external vendors for development of new processes and material sourcing

• Design and evaluate product prototypes with biomechanical test models and experimentation

• Design, build, and verify test hardware, software, and systems to simulate real world conditions and measure outputs 

• Define and conduct procedures to evaluate product performance using benchtop testing and simulation methods, including efficacy, reliability, verification, and validation

• Perform statistical data analysis and interpretation and report findings to project team

• Perform and document work in accordance with FDA/ISO regulations, including test protocols, test results, and other requirements

• Work with clinical team to conduct pilot studies and other investigations

• Communicate with professionals in the field at all levels and transfer information into product improvement

• Understand and master complex biomechanical systems with sound mechanical principles

• Work in a fast paced environment and meet critical deadlines

• Problem solve issues with attention to detail and implement corrective action where necessary

• Provide general engineering support in R&D 

What we're looking for

In this role, you’ll need …

Required experience:

•       MS or PhD in Mechanical or Biomedical Engineering; other scientific disciplines considered

•       5+ years of experience in biomedical research and/or product development

•       Experience in design, execution, and analysis of benchtop experiments in the biomechanics field

•       Experience with 3D modeling using CAD software, Solidworks preferred

Desired experience:

•       Experience with new process development and validation

•       Experience with finite element analysis

•       Experience in medical device industry, orthodontics and/or dental industry

•       Experience with scripting/programming