Engineer Validation
Core
Support new product and process introductions, Computer System Validation (CSV), and equipment/process qualifications (IQ/OQ/PQ) for medical device manufacturing systems and digital tools.
Role type
Validation Engineer (Medical Device Manufacturing)
Builds
Manufacturing systems, software applications, automation solutions, and digital tools
Domain
Medical device manufacturing / Regulated manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Manufacturing process qualification, Computer System Validation (CSV), IQ/OQ/PQ execution, Risk management (PFMEA, Control Plans), Measurement System Analysis (MSA), Process capability analysis, GD&T interpretation, Statistical process control, Regulatory compliance (GMP, FDA, ISO 13485)
Preferred skills
Project management, Multitasking, Cross-functional collaboration, Continuous improvement, Root-cause problem-solving
Technologies
Manufacturing execution systems, Validation documentation tools, Statistical analysis software
Responsibilities
Develop and execute validation documentation (plans, risk assessments, test protocols, reports), Design and document process/equipment qualifications, Review and maintain validation and technical documentation, Collaborate on inspection methods and acceptance criteria, Conduct MSA and capability studies, Ensure compliance with regulatory and safety requirements
Seniority
Mid-level, hands-on IC
