Senior MedTech Manufacturing Leader

MindAffect; Netherlands; Hybrid; EUR 110,000 - 140,000; Full time

Job summary

MindAffect is a Dutch health-tech company transitioning Sofi into scalable production. We seek a Senior Medical Device Engineer to build and own the manufacturing and operational backbone behind Sofi®, integrating a proprietary EEG headset, an EEG/audio amplifier, and Rapid-CAEP analysis into one platform.

The role bridges engineering, manufacturing, and operations, taking a device from late R&D into regulated production (ISO 13485) and partnering with external manufacturers.

Qualifications

• 5+ years of experience in medical device manufacturing or hardware operations in Europe.
• Hands-on experience bringing hardware-software medical devices from development into production.
• Proven experience working with external manufacturing partners or OEMs.
• Strong familiarity with ISO 13485 environments.

Responsibilities

• Lead evaluation, selection, and onboarding of external manufacturing partners.
• Translate R&D outputs into production-ready deliverables (BOMs, assembly instructions, calibration specs, DMR).
• Define the manufacturing strategy aligned with CE MDR and FDA frameworks.
• Own Phase 2: production planning, purchasing and supplier performance management.
• Oversee quality, traceability, and change-control processes.
• Drive continuous improvement in manufacturing quality, scalability and cost.

Skills

Experience in medical device manuf.

Hardware operations

External manufacturing partners

ISO 13485 environments

Education

Master’s degree in Mechanical/Electrical/Biomedical/Industrial Eng.

Job description

MindAffect is a Dutch health-tech company transitioning Sofi into scalable production. We seek a Senior Medical Device Engineer to build and own the manufacturing and operational backbone behind Sofi®, integrating a proprietary EEG headset, an EEG/audio amplifier, and Rapid-CAEP analysis into one platform.

The role bridges engineering, manufacturing, and operations, taking a device from late R&D into regulated production (ISO 13485) and partnering with external manufacturers.