R&D Engineer – Qualification & Validation (m/w/d) - befristet auf 3 Jahre
Core
Ensure compliance and quality of dialysis devices, methods, and systems through qualification and validation activities in a regulated MedTech environment.
Role type
R&D Engineer (Qualification & Validation)
Builds
Dialysis devices and catheters for patients with kidney diseases
Domain
Medical Technology (MedTech) / Dialysis
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Equipment qualification (DQ/IQ/OQ/PQ), Method validation, Computer Software Validation (CSV), Change management, Regulatory compliance (ISO 13485, GMP, GAMP5, ALCOA+)
Preferred skills
Risk analysis, Audit support, Lifecycle maintenance
Technologies
GAMP5, ALCOA+, ISO 13485, GMP
Responsibilities
Plan and execute DQ, IQ, OQ, and PQ for laboratory and test equipment; Develop and validate analytical methods; Ensure compliance of computer-controlled software; Initiate and implement changes with impact assessments; Support equipment lifecycle and maintenance; Assist in audits and inspections; Create and review validation documents, SOPs, and risk analyses
Seniority
Mid-Senior, hands-on IC