# Manufacturing & NPI Engineer

[Megoafek](https://gurify.com/jobs?q=Megoafek) · Afek, Israel · Posted 6 weeks ago

[Apply on the original posting → (opens in a new tab)](https://www.comeet.com/jobs/megoafek/7A.003/manufacturing--npi-engineer/04.E6E)

## Job 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

**Live in Megoafek’s hiring system.** Read from the company's own applicant tracking system, not reposted from a job board — so it's a real, open requisition rather than an ad that outlived the role.

We remove it as soon as it disappears at source.

## More jobs like this

- KE [NPI / Product Operations Engineer](https://gurify.com/job/npi-product-operations-engineer-at-kelatechnologies-b0eaaa301cef) Kelatechnologies · Tel Aviv-Yafo, Israel · 3 weeks ago
- NS [Founding Data Engineer](https://gurify.com/job/founding-data-engineer-at-noma-security-130708052df8) Noma Security · Tel Aviv-Yafo, Israel · last week
- NO [Head of Solutions Engineer](https://gurify.com/job/head-of-solutions-engineer-at-notch-01ee495af518) Notch · Ramat Gan, Israel · last week
- SE [Senior QA Engineer (Data Oriented)](https://gurify.com/job/senior-qa-engineer-data-oriented-at-seemplicity-d6742fafaaa9) Seemplicity · Tel Aviv-Yafo, Israel · last week
- CO [Senior AI Applications Backend Engineer](https://gurify.com/job/senior-ai-applications-backend-engineer-at-cognyte-bc986a78cca8) Cognyte · Herzliya, Israel · 4 days ago
- FU [Mid-Level Backend Engineer](https://gurify.com/job/mid-level-backend-engineer-at-fullpath-04a319f827da) Fullpath · Jerusalem, Israel · 6 days ago

```json
{"@context":"https://schema.org/","@type":"JobPosting","title":"Manufacturing \u0026 NPI Engineer","description":"\u003Cp\u003E\u2666 Lead / participate in the NPI process along the stage-gates R\u0026amp;D process for a system \u2013 medical devices class II. work packages, gate-passage criteria, decision records.\u003C/p\u003E\u003Cp\u003E\u2666 Develop and establish new production lines and processes; define process flow, equipment, tooling and fixtures, test systems (leak test, HF welding).\u003C/p\u003E\u003Cp\u003E\u2666 Own Design-for-Manufacturing (DFM/DFA) - engineering feedback to R\u0026amp;D during development phases, optimization for manufacturability and cost.\u003C/p\u003E\u003Cp\u003E\u2666 Multi-disciplinary systems integration - integrate mechanical, pneumatic and electromechanical/electronic components (compression garments, control units, tube-harness assemblies).\u003C/p\u003E\u003Cp\u003E\u2666 Process validation (IQ/OQ/PQ) including GR\u0026amp;R - write protocols and reports, execute and approve.\u003C/p\u003E\u003Cp\u003E\u2666 Own production transfers Israel \u2192 CMO: prepare the transfer package, define process-equivalency criteria, approve pilot runs remotely in coordination with the Local-site engineer.\u003C/p\u003E\u003Cp\u003E\u2666 Change control per ECR/ECO procedure - ECR as initiation trigger, ECO as binding authority; route in Arena PLM.\u003C/p\u003E\u003Cp\u003E\u2666 Manage nonconformances (NCR): containment, root cause investigation, corrective actions (CAPA), return-to-production in coordination with QA.\u003C/p\u003E\u003Cp\u003E\u2666 Technical management of suppliers and subcontractors - process control, specification compliance, performance monitoring, audits.\u003C/p\u003E\u003Cp\u003E\u2666 Maintain controlled documentation - work instructions, drawings, inspection specifications; aligned to the controlled revision of source documentation.\u003C/p\u003E\u003Cp\u003E\u2666 Full member of the Engineering team - receives assignments from the Engineering Manager. Structured weekly report: line status, open NCRs, risks.\u003C/p\u003E\u003Ch3\u003ERequirements\u003C/h3\u003E\u003Ch3\u003EEducation, Courses \u0026amp; Certifications\u003C/h3\u003E\u003Cp\u003E\u2666 B.Sc. in Mechanical / Industrial / Mechatronics / Systems / Electrical Engineering - required.\u003C/p\u003E\u003Cp\u003E\u2666 Background in Systems Engineering - significant advantage.\u003C/p\u003E\u003Cp\u003E\u2666 Training in process validation or quality control - advantage.\u003C/p\u003E\u003Ch3\u003EProfessional Experience \u0026amp; Knowledge\u003C/h3\u003E\u003Cp\u003E\u2666 5\u002B years of manufacturing engineering experience in an industrial environment - required.\u003C/p\u003E\u003Cp\u003E\u2666 Experience integrating multi-disciplinary systems (mechanical \u002B pneumatic \u002B electromechanical/electronic) - required.\u003C/p\u003E\u003Cp\u003E\u2666 Experience in medical devices or a regulated industry (ISO 13485 / GMP) - required.\u003C/p\u003E\u003Cp\u003E\u2666 Experience in production transfers / line ramp-up - significant advantage.\u003C/p\u003E\u003Cp\u003E\u2666 Experience in an ERP environment, especially PRIORITY - advantage.\u003C/p\u003E\u003Cp\u003E\u2666 Experience with Arena PLM or other PLM - advantage.\u003C/p\u003E\u003Cp\u003E\u2666 Experience working with foreign companies / international teams - advantage.\u003C/p\u003E\u003Cp\u003E\u2666 Reading and interpreting drawings, electrical and pneumatic schematics, GD\u0026amp;T.\u003C/p\u003E\u003Cp\u003E\u2666 Validations (IQ/OQ/PQ), GR\u0026amp;R, and failure investigation (8D, 5-Why).\u003C/p\u003E\u003Cp\u003E\u2666 Experience in NPI / stage-gate and leading production-establishment projects.\u003C/p\u003E\u003Cp\u003E\u2666 High Proficiency in OFFICE software and technical writing in English.\u003C/p\u003E\u003Cp\u003E\u2666 English - high proficiency\u003C/p\u003E","identifier":{"@type":"PropertyValue","name":"Gurify","value":"manufacturing-npi-engineer-at-megoafek-d661d678acb0"},"url":"https://gurify.com/job/manufacturing-npi-engineer-at-megoafek-d661d678acb0","datePosted":"2026-07-21","validThrough":"2026-10-18T23:59:59Z","hiringOrganization":{"@type":"Organization","name":"Megoafek","sameAs":"https://www.comeet.com/jobs/megoafek"},"directApply":false,"jobLocation":{"@type":"Place","address":{"@type":"PostalAddress","addressCountry":"IL","addressLocality":"Afek"}}}
```

```json
{"@context":"https://schema.org/","@type":"BreadcrumbList","itemListElement":[{"@type":"ListItem","position":1,"name":"Jobs","item":"https://gurify.com/jobs"},{"@type":"ListItem","position":2,"name":"Israel","item":"https://gurify.com/jobs/israel"},{"@type":"ListItem","position":3,"name":"Manufacturing \u0026 NPI Engineer","item":"https://gurify.com/job/manufacturing-npi-engineer-at-megoafek-d661d678acb0"}]}
```