♦ Lead / participate in the NPI process along the stage-gates R&D process for a system – medical devices class II. work packages, gate-passage criteria, decision records.
♦ Develop and establish new production lines and processes; define process flow, equipment, tooling and fixtures, test systems (leak test, HF welding).
♦ Own Design-for-Manufacturing (DFM/DFA) - engineering feedback to R&D during development phases, optimization for manufacturability and cost.
♦ Multi-disciplinary systems integration - integrate mechanical, pneumatic and electromechanical/electronic components (compression garments, control units, tube-harness assemblies).
♦ Process validation (IQ/OQ/PQ) including GR&R - write protocols and reports, execute and approve.
♦ Own production transfers Israel → CMO: prepare the transfer package, define process-equivalency criteria, approve pilot runs remotely in coordination with the Local-site engineer.
♦ Change control per ECR/ECO procedure - ECR as initiation trigger, ECO as binding authority; route in Arena PLM.
♦ Manage nonconformances (NCR): containment, root cause investigation, corrective actions (CAPA), return-to-production in coordination with QA.
♦ Technical management of suppliers and subcontractors - process control, specification compliance, performance monitoring, audits.
♦ Maintain controlled documentation - work instructions, drawings, inspection specifications; aligned to the controlled revision of source documentation.
♦ Full member of the Engineering team - receives assignments from the Engineering Manager. Structured weekly report: line status, open NCRs, risks.