Manufacturing & NPI Engineer
Posted 14 days ago · 0 applicants
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The role in plain words
- B.Sc. in Mechanical / Industrial / Mechatronics / Systems / Electrical Engineering
- 5+ years of manufacturing engineering experience in an industrial environment
- Experience integrating multi-disciplinary systems (mechanical + pneumatic + electromechanical/electronic)
- Reading and interpreting drawings, electrical and pneumatic schematics, GD&T
- Validations (IQ/OQ/PQ), GR&R, and failure investigation (8D, 5-Why)
- Training in process validation or quality control
- Priority ERP
- Arena PLM or other PLM
- Experience working with foreign companies / international teams
Extracted from the job description · kept up to date automatically
Who this suits
Full job description
Original listing · kept for reference♦ 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
Questions about this role
- This listing did not state a salary. We only show pay when the employer publishes it.
- B.Sc. in Mechanical / Industrial / Mechatronics / Systems / Electrical Engineering, 5+ years of manufacturing engineering experience in an industrial environment, Experience integrating multi-disciplinary systems (mechanical + pneumatic + electromechanical/electronic), Reading and interpreting drawings, electrical and pneumatic schematics, GD&T, Validations (IQ/OQ/PQ), GR&R, and failure investigation (8D, 5-Why)