Design Control Engineer • Senior

Who you are

You have a strong background in design controls and quality management systems, particularly in regulated industries like medical devices. Your experience includes establishing and maintaining design and development procedures, ensuring compliance with standards such as ISO 13485. You are detail-oriented and understand the importance of traceability and verification in product development.

You possess excellent communication skills, allowing you to collaborate effectively with cross-functional teams including engineering, operations, and quality assurance. Your ability to assess design changes and their impact on quality management systems is a key strength. You are proactive in identifying potential issues and implementing solutions to ensure compliance and product quality.

What you'll do

As the Design Control Engineer at Dandy, you will be responsible for building and owning the design controls execution for both hardware and software products. You will establish and maintain Dandy's Design & Development procedures, ensuring that all necessary documentation such as Design Plans, Design Inputs/Outputs, and Verification and Validation plans are created and maintained. Your role will involve defining a scalable design evidence model that fits Dandy's distributed development structure and multi-site operations.

You will conduct design-change impact assessments within the QMS change control process, ensuring that all relevant changes are documented and evaluated for their impact on product quality and compliance. You will work closely with various teams to ensure that design control evidence is consistently created and maintained for new products and changes. Your expertise will help Dandy simplify and modernize the dental industry through innovative technology solutions.

What we offer

At Dandy, we are committed to transforming the dental industry and empowering clinicians with technology. We offer a collaborative work environment where your contributions will have a direct impact on our mission. Join us in building the operating system for dental offices around the world, and be part of a team that values innovation and excellence.