Daily Duties:

Lead projects focused on medical device governance, risk and compliance.
Hands on system selection, acquisition, specification, configuration, design assurance, implementation etc.
Technical evaluations of enterprise level (non-product) systems such as embedded devices, applications, middleware, databases, infrastructure and IT networks
Lead requirement elicitation and detailed design discussions across several business units (developers, analysts, R&D, quality/regulatory etc)

Must Have Requirements:

At least 5 years experience with Non-Product Software Validation
Experience with regulatory compliance or FDA regulations (FDA 21 CFR Part 820, ISO 13485, ISO 14971)
Experience with guidance such as NIST, IEC, GAMP, GDPR or Data Integrity
Experience designing and performing quality and compliance risk assessments
Experience with software development methods (SDLC)
Bachelors degree in engineering, science or a similar discipline
US Citizenship required

Additional Qualifications:

Experience working in a manufacturing, business or a laboratory environment
Knowledge of security-by-design, change management, contingency planning, disaster recovery
Certifications a plus: CISA, CRISC, CGEIT, CISSP, GSSP, CSSLP, SSCP, CPP, CSQE, CQA

Sthree US is acting as an Employment Business in relation to this vacancy.

Summary
Real Staffing
Software Validation Engineer at Real Staffing (San Francisco, CA) (allows remote)

Tags: validation