Senior Engineer Validation
Core
Support new product and process introductions by executing validation activities to industrialize and transfer new products into manufacturing for medical devices.
Role type
Senior Validation Engineer
Builds
Manufacturing-ready products and processes for medical device clients
Domain
Medical Devices / Regulated Manufacturing
Required skills
Validation Engineering, Manufacturing Engineering, Quality Engineering, IQ/OQ/PQ execution, GMP, FDA QSR, ISO 13485, Risk Management, Computer System Validation (CSV)
Preferred skills
PFMEA, Control Plans, PPAP, Process Qualification, MSA, Gage R&R, Statistical Analysis (Minitab), New Product Development (NPD), Design Transfer, Project Management
Technologies
Minitab, FDA QSR 21 CFR Part 820, ISO 60601
Responsibilities
Support new product and process introductions in accordance with Product Development Process (PDP), Design Controls, and Quality System requirements; Collaborate with R&D, Manufacturing Engineering, Quality, Regulatory, and Operations teams to industrialize and transfer new products into manufacturing; Participate in manufacturing readiness activities including pilot builds, process characterization, verification, and production ramp up; Develop, execute, and maintain validation documentation including Validation Plans, Risk Assessments, Protocols, Traceability Matrices, and Final Reports; Lead and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities for manufacturing equipment, processes, tooling, fixtures, and production systems; Ensure validation activities comply with GMP, FDA, ISO 13485, and internal quality requirements.
Seniority
Senior, hands-on IC