- 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
- 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