Senior Software Quality Assurance Engineer

at  Element Science

QUALIFICATIONS:

• Bachelor’s degree in Software, Electrical Engineering, or Computer Science.
• A minimum of 7+ years of recent medical device experience.
• Experience writing and executing validation/verification plans, protocols, and software risk analysis on Medical Devices.
• Medical Device experience covering embedded software.
• Strong cross-functional communication skills.
• Strong written skills to define and document V&V outputs.
• Experience in C or other scripting languages is desirable.
• Experience in automation frameworks.
• Experience in Threat Modeling and Software Risks.
• Working knowledge of FDA, Software Validation Guidance, 21 CFR part 820, IEC 62304, and IEC 82304-1.

SUMMARY OF ROLE:

As a Senior Software Quality Assurance Engineer, you will work with the software organization to act as a champion of Quality Assurance and Engineering activities throughout software development lifecycle. You hold your work and teams to the highest quality standards and ensure that all corporate business requirements, regulations, and other standards are met, as applicable. This is a hands-on role where you will apply intensive, self-directed and diversified knowledge of engineering and quality principles for Element Science software and platforms.

RESPONSIBILITIES:

• Author validation plans, protocols, software risk analyses for a medical device.
• Execute validation testing based on product requirements.
• Create, review and approve reports for V&V software testing and test scripts.
• Collaborate with firmware and software R&D engineers on improvements or new products.
• Provide guidance to Threat Modeling for cybersecurity.
• Coach and mentor junior team members on current best practices.
• Lead and participate in project teams assigned to new products.
• Support and investigate customers complaints related to product software.
• Involved in monitoring software anomalies.