Manufacturing & NPI Engineer

♦  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.

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