Software Validation Engineer 2
Core
Lead and support software validations for custom-developed, vendor, and commercial off-the-shelf software applications used for patient care, manufacturing, and quality systems.
Role type
Software Validation Engineer
Builds
Software validation packages and documentation for medical and non-medical device software
Domain
Medical device manufacturing / Software validation
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Software validation, regulatory compliance, risk assessment, code and design review, quality plan development, non-conformance reporting, CAPA mitigation, supplier documentation review
Preferred skills
C, C++, Python, MATLAB, SQL, MCSE, ASQ yellow+, FE (EIT)
Technologies
Microsoft Word, PowerPoint, Excel, C, C++, Python, MATLAB, SQL
Responsibilities
Collaborate with groups on software validation projects, review and approve software validation documentation, produce software validation packages, adhere to applicable regulatory requirements, support non-conformance and CAPA mitigation efforts
Seniority
Mid-level, independent contributor
