Technical Manager - Medical Devices

Technical Manager, Factory

Company: Nihon Kohden Middle East (NKME)
Location: Dubai, UAE
Department: Factory / Operations
Reports to: Factory Manager (or Head of Operations)
Direct Reports: Process/Validation Engineers, Maintenance Engineers/Technicians; dotted-line to Warehouse/Logistics & QC/Lab teams
Employment: Full-time

Role Purpose

Lead the site’s technical and cross-functional operations—spanning factory, logistics/warehouse, production & manufacturing, laboratory/QC, Quality Assurance (QA), and Regulatory Affairs (RA)—to deliver safe, compliant, on-time, and cost-efficient output under ISO 13485 and applicable regional regulations (MOHAP/UAE, SFDA, EU MDR, FDA as applicable).

Key Responsibilities1) Cross-functional site leadership

• Own technical governance across factory, logistics, production, lab, QA & RA; set priorities, remove roadblocks, and ensure seamless handoffs (incoming materials → manufacturing → testing → release → dispatch).
• Chair daily/weekly tier meetings (SQDCP), escalate risks, and drive actions to closure.

2) Logistics & warehouse operations

• Oversee inbound/outbound, customs/FZ compliance (JAFZA/DWC or equivalent), 3PL coordination, and traceability/UDI controls.
• Optimize layout, FEFO/lot control, cycle counts, and inventory accuracy; implement WMS/ERP transactions discipline.
• Ensure handling of regulated/temperature-sensitive materials where applicable; maintain shipping QA holds/release process with QA.

3) Production & manufacturing engineering

• Design/transfer/sustain processes, line balancing, takt & work standards; author SOP/WI, PFMEA, control plans.
• Plan/execute IQ/OQ/PQ; maintain the Validation Master Plan and complete DQ/IQ/OQ/PQ files.
• Drive OEE, SMED, FPY, scrap reduction, and cost-to-serve improvements.

4) Laboratory / QC & testing

• Lead QC/Lab operations (incoming, in-process, final), metrology & calibration, and method/equipment qualification.
• Ensure environmental monitoring/cleanroom discipline (as applicable) and timely COA/COT documentation.
• Define lab TAT targets; manage OOS/OOE investigations with QA.

5) Quality Assurance (QA)

• Sustain ISO 13485 QMS and risk management per ISO 14971; enforce GDP/GMP documentation.
• Ensure complete DMR/DHR, labeling/UDI compliance, and change control.
• Lead deviations/NCRs/CAPA, internal audits, supplier quality actions, and readiness for NB/regulatory audits.

6) Regulatory Affairs (RA)

• Coordinate technical files, declarations, risk/clinical evidence links, and labeling for MOHAP, SFDA, EU MDR, FDA as relevant.
• Support registrations, vigilance/post-market surveillance, and UDI/EUDAMED or equivalent submissions.
• Ensure manufacturing/labeling changes remain in regulatory compliance; maintain market-specific variants.

7) EHS & statutory

• Own machinery safety, LOTO, chemical handling, PPE, and statutory inspections; lead incident investigations and action closure.

8) Capex, digital & continuous improvement

• Build business cases and manage Capex from URS/DQ → FAT/SAT → handover.
• Deploy CMMS/EAM, WMS, ERP/PLM, SPC/MSA dashboards; lead Kaizen/5S/VSM programs.

9) People leadership & vendors

• Develop skills matrices and training for engineers/technicians, warehouse & lab teams (in coordination with function leads).
• Manage OEMs/service providers and key suppliers; negotiate SLAs and performance metrics.

KPIs

• Inventory accuracy (cycle count): ≥ 98%; OTIF (inbound/outbound): ≥ 98%
• Critical equipment uptime: ≥ 95%; PM & calibration on-time: ≥ 98%
• OEE improvement: +5–10% YoY on focus lines; FPY: ≥ 98%; scrap ≤ target
• DHR completeness / lot traceability: 100%; zero late DHR closures
• CAPA/deviation closure: within SLA; zero repeat major audit findings
• Regulatory milestones: submissions/variations on time; zero compliance slippages
• Lab TAT: meets target with ≤ target OOS rate
• EHS: zero recordable incidents; action closure ≥ 95% on time
• CI/Capex: savings & ROI delivered per AOP

Qualifications & Experience

• Bachelor’s in Mechanical/Electrical/Industrial/Manufacturing Engineering (Master’s preferred).
• 10+ years in manufacturing/operations within medical devices/diagnostics or highly regulated industry, with proven cross-functional exposure to logistics/warehouse, production, laboratory/QC, QA & RA.
• Hands-on leadership of process/equipment validation (IQ/OQ/PQ), tech transfer, and change control.
• Deep QMS knowledge (ISO 13485, ISO 14971) and working familiarity with EU MDR / FDA 21 CFR 820 / MOHAP / SFDA.
• Practical experience with WMS/ERP/PLM, CMMS/EAM, SPC/MSA, PFMEA/control plans, and Lean/Six Sigma (Green/Black Belt desirable).
• GCC/Dubai logistics compliance (customs, HS codes, free-zone processes) is a strong plus.
• Strong vendor/OEM management and cross-functional stakeholder leadership.

Core Competencies

• Advanced troubleshooting & RCA (5-Why, Fishbone, FTA) and data-driven decision making
• Excellent documentation discipline and audit readiness
• Planning, prioritization, and change management in fast-moving environments
• Coaching, team development, and effective cross-functional influence

Job Type: Full-time

Pay: AED15,000.00 - AED25,000.00 per month

Application Question(s):

• What is your knowledge of ISO 13485, GMP, and UAE/SFDA/MOHAP regulations?
• Do have experience in servicing, maintaining, or managing medical devices?
• What is your notice period in days?
• What is your monthly salary expectation?