Software Quality Engineer - Onsite (DV2026)

TEMP TO HIRE

Description:

This role centers on medical device software quality engineering, ensuring compliance, safety, and functionality throughout the software development life cycle. Key responsibilities include leading software verification and validation activities—such as drafting and reviewing test plans, protocols, reports, and non-product software assessments—while maintaining strict requirements traceability. 

What you’ll do:

Support software verification & validation (V&V) activities (test protocols, plans, reports), including non-product software assessment.

Support product cybersecurity assessments in collaboration with cross-functional teams.

Review software and system documentation to ensure quality and compliance.

Maintain requirements traceability and support SDLC processes.

Perform risk assessments (FMEA, hazard analysis) and drive issue resolution.

Participate in sustaining engineering activities, including post-release support and issue resolution, may participate in design reviews and represent Quality in approvals.

Support post-release changes, audits, and quality system improvements.

Collaborate cross-functionally to ensure compliance with FDA, ISO 13485, IEC 62304.