Engineer Verification & Validation
Core
Design, develop, execute, document, and implement software, machinery, process, and new product validations for Medline plant divisions to ensure compliance with legal standards and optimal production quality.
Role type
Senior IC verification and validation engineer (medical devices/manufacturing)
Builds
Validated processes, machinery, and new products for Medline Industries
Domain
Medical devices / Surgical / Pharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Statistical analysis (CPK, PPK, GR&R, ANOVA), Lean Manufacturing, 6 Sigma, MKOS methodology, Internal quality auditing, FDA CFR 21.820/11 compliance, ISO-13485, ISO-11607, ISO-5356, Kaizen, CAPAS, MCORs, Cost/efficiency/quality monitoring, Project implementation, Technical knowledge (mechanics, hydraulics, pneumatics, electricity, electronics, thermodynamics, thermoforming)
Preferred skills
Master's degree in Quality or Statistics, Internal quality auditor certification, Basic computer system programming
Technologies
Minitab, AutoCAD, AS400, M-Power, Pack Draw, Macros, Adobe, Microsoft Office (Project, Excel, Word, PowerPoint, Outlook)
Responsibilities
Ensure protocols comply with ISO-13485, ISO-11607, FDA CFR 21.820, and CFR21.11; Design, present, and approve engineering validation studies with senior leadership; Execute planned validations and implement resulting procedures, work instructions, setups, and inspection methods; Conduct statistical analysis for decision-making; Lead Kaizen events, MKOS programs, and CAPAS; Monitor and improve cost, efficiency, quality, and safety results; Respond to audits.
Seniority
Senior, hands-on IC
