Quality Software Validation Engineer

Company info:

Neuralink Corporation is a neurotechnology company that develops implantable brain-machine interfaces to connect humans to technology. Co-founded by Elon Musk, Max Hodak, and Paul Merolla. Our mission is to build devices that have the potential to help people with paralysis and invent new technologies that could expand our abilities, our community, and our world.

Team info:

Job Responsibilities:

Support cross-functional teams in software validation and communicate with experts to validate software packages, devices, and data systems (for software as a part of medical device, non-medical device software, and medical device as a software). Write software validation standard operating procedures (SOPs) and be responsible for ensuring software validation meets regulatory compliance. Draft and execute software validation protocols. Drive quality engineering software validation activities designed to make it easier for software engineers to innovate. Translate regulatory requirements into action clearly and effectively. Test different software and guide developers in building software that meets Code of Federal Regulations (CFR) requirements by design. Perform and apply software risk assessments and audits.

Key qualifications:

regulated software validation and building software validation programs; software validation and audits in the Food and Drug Administration (FDA) industry; software risk assessments in the FDA industry; quality assurance, software validation as part of process validation and design controls, risk management, and statistical techniques; and GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems.

Preferred qualifications:

Master's degree or foreign equivalent in Biotechnology or related field, plus three (3) years of experience as a Software Validation Manager, Software Validation Specialist, or related occupation.