Sr. Design Quality Engineer

Posted Tuesday, June 23, 2026 at 4:00 AM

Avalign produces innovative, high-performance, and cost-effective medical devices with a particular focus on high growth and ingenuity. Our team is growing quickly and proud of the fact that our custom-made devices continue to make a huge difference in the lives of medical professionals and their patients. Our employees are actively involved in the design, engineering and manufacture of technologically advanced medical devices that ensure that we meet our customer’s quality specifications for each product we produce.

The Design Quality Engineer will be responsible for the quality and regulatory related activities associated with new product development. New product development activities will occur in the contract development context and in the specification developer context. These activities span all aspects of the new product development process. The Design Quality Engineer will advise customers in the contract development context how to incorporate Critical-To-Quality (CTQ) and Design-For-Inspection (DFI) into the development process.

The Design Quality Engineer will provide CTQ and DFI input internally while ensuring that Avalign specification development activities conducted by Research and Development (R&D) comply with associated policies, procedures and work instructions as outlined in the design control elements of the Quality Management System (QMS).

The Design Quality Engineer will be responsible to ensure that regulatory compliant technical documentation is compiled and for ensuring the ongoing compliance of the technical documentation for assigned Avalign Technologies design owned products. The Design Quality Engineer will assist in regulatory filings for Avalign Technologies design owned products whether this includes Avalign filing, supporting the customer to file, or a third party filing the regulatory submission.

A working knowledge of related global design regulations is required. (ISO 13485, ISO 14971, 21 CFR Part 820, and, preferably, EU Medical Device Regulation) The position requires a hands‑on self‑directed style, and the ability to influence and effectively communicate vertically, horizontally, across functions, externally with customers and internally with co‑workers. The ideal candidate must demonstrate ability to self‑direct, strong analytical abilities, and strong verbal and written communication skills.

The position reports directly to the Director of Regulatory Affairs.

• Responsible for supporting a design control quality system that is complaint to ISO 13485 (latest revision), the Medical Device Directives (while active), and the EU Medical Device Regulations (MDR).
• Supports, reviews, and approves the following activities associated with new product development: identification and documentation of user needs, design inputs, outputs, verification, validation, risk assessment, and design change activities to demonstrate new product designs are supported by objective evidence in the design history file prior to product launch.
• Participate in supply chain development through Avalign division and external supplier selection and qualification with the new product development team.
• Participates in design reviews as required by the design control and development processes.
• Serve as GD&T expert for contract developer and specification developer activities.
• Assist project managers with design transfer planning and execution including advising on Avalign and vendor manufacturing process validations to support new product development.
• Support processes for Medical Device Reporting and Complaints for Avalign as specification developer products.
• Ensure required design documentation is retained in design history files and technical files to support regulatory submissions and audits.
• Support and maintain all regulatory filings for all Avalign Technologies design owned products whether this includes Avalign filing, supporting the customer to file, or a third party filing the regulatory submission.
• Perform corporate internal audits, either as a supporting auditor or as the lead auditor.
• Participate in external audits.
• Conduct post…