The Quality Design Controls Engineer will serve as the centralized owner of design control execution for software products and software-containing devices. This role involves ensuring the creation and maintenance of software design control evidence for new software releases and changes, working within the existing quality management system (QMS) change control process.
Responsibilities

+ Establish and maintain software Design & Development procedures and supporting templates such as Design Plans, Software Requirements Specifications, Design Inputs/Outputs, Design Reviews, V&V plans, and DHF structures.

+ Define a scalable DHF/design evidence model suitable for distributed software development, including SaMD classification considerations and SOUP management.

+ Assess the impact of software changes on design-control processes within the QMS change control framework.

+ Ensure proper linkage of design-change work to controlled documents, records, and...