Design Assurance Engineer II

Position Summary: The Design Assurance Engineer II supports the development, manufacturing, and lifecycle management of dental consumables by ensuring design control, risk management, quality, and regulatory requirements are effectively incorporated throughout the product development and manufacturing processes. This role owns assigned Design Assurance deliverables, including design changes, requirements traceability, and verification and validation support. Working cross-functionally with R&D, Manufacturing, Regulatory Affairs, Quality, and Operations, this role contributes to product risk management, test method development, data analysis, reliability evaluations, investigations, CAPA activities, and process validation.

Essential Duties and Responsibilities:

• With minimal supervision, owns defined design assurance deliverables (e.g., design changes, traceability, V&V support).

• Supports development and review of design inputs, outputs, and verification/validation plans.

• Contributes to and maintain product risk management files (FMEA, hazard analysis). 

• Supports test method development, data analysis, and reliability evaluations. 

• Participates in investigations, CAPA activities, and process validation support.  

• Ensures readiness for design reviews and phase/toll-gate activities.

• Actively participates in continuous improvement activities including but not limited to Kaizen and 5S events, Problem Solving Process, Value Stream Mapping, and Transaction Process Improvement.

• Effectively collaborates with cross-functional teams to meet business objectives.

• Adheres to all company policies and procedures including safety and quality.

• Travels up to 5% domestically.

Incidental Duties: The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.