Senior Software Design Assurance Engineer

Newark, DE, United States

Marlborough, MA, United States

The Senior Software Design Assurance Engineer is responsible for ensuring the quality, safety, reliability, and regulatory compliance of medical device software throughout the product lifecycle. This role focuses on establishing and maintaining robust software design controls, driving rigorous verification and validation processes, and collaborating with engineering teams to deliver dependable and compliant software solutions for both standalone and embedded medical devices.

**Knowledge**

+ In-depth understanding of medical device regulations (e.g., FDA, EU MDR, ISO 13485, IEC 62304) for Software as a Medical Device (SaMD) and embedded systems.
+ Strong grasp of the software development lifecycle (SDLC) and its application to safety-critical systems.
+ Expertise in risk management per ISO 14971, including Hazard Analysis and FMEA.
+ Fa...