Manufacturing & NPI Engineer

Description

♦ 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.

Requirements

• Education, Courses & Certifications
• ♦ B.Sc. in Mechanical / Industrial / Mechatronics / Systems / Electrical Engineering - required.
• ♦ Background in Systems Engineering - significant advantage.
• ♦ Training in process validation or quality control - advantage.
• Professional Experience & Knowledge
• ♦ 5+ years of manufacturing engineering experience in an industrial environment - required.
• ♦ Experience integrating multi-disciplinary systems (mechanical + pneumatic + electromechanical/electronic) - required.
• ♦ Experience in medical devices or a regulated industry (ISO 13485 / GMP) - required.
• ♦ Experience in production transfers / line ramp-up - significant advantage.
• ♦ Experience in an ERP environment, especially PRIORITY - advantage.
• ♦ Experience with Arena PLM or other PLM - advantage.
• ♦ Experience working with foreign companies / international teams - advantage.
• ♦ Reading and interpreting drawings, electrical and pneumatic schematics, GD&T.
• ♦ Validations (IQ/OQ/PQ), GR&R, and failure investigation (8D, 5-Why).
• ♦ Experience in NPI / stage-gate and leading production-establishment projects.
• ♦ High Proficiency in OFFICE software and technical writing in English.
• ♦ English - high proficiency