Software Validation Engineer at Real Staffing

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.

Please let the company know you found this position on so we can keep providing you with quality jobs.