Senior Medical Device Manufacturing & Operations Lead

MindAffect; Ede; On-site; EUR 90,000 - 120,000; Full time

Job summary

MindAffect is seeking a Senior Medical Device Manufacturing Engineer to lead the establishment and scaling of the Sofi production platform. You will own manufacturing readiness, partner onboarding, and governance in CE MDR and FDA contexts, ensuring transfer from development to regulated production.

You will subsequently manage the operational backbone, including supply chain, production oversight, and lifecycle support, with potential for broader leadership roles as the company scales.

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.
• Master’s degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Industrial Engineering, or similar.
• Experience establishing manufacturing processes, documentation, and production readiness.
• Understanding of manufacturing and assembly processes for PCB-based electronics, complex enclosures, connectors, and cables.
• Ability to work cross-functionally with R&D, regulatory, quality, and external partners.

Responsibilities

• Phase 1: Build Manufacturing & Operational Readiness — lead evaluation/selection of external manufacturing partners, perform due diligence, transfer design to production, define manufacturing strategy within CE MDR and FDA frameworks, ensure manufacturability and create production-ready deliverables (BOMs, supplier lists, assembly instructions, calibration specs, DMR).
• Phase 1 cont.: establish serialization, traceability, DHR processes; draft supplier/quality agreements and SOPs; collaborate with engineering to optimize for scalable production.
• Phase 2: Run Manufacturing, Supply Chain & Operations — manage relationships with partners and vendors, own production planning and procurement, maintain documentation and change control, oversee quality and reliability, design repair/warranty processes, set up logistics and distributor support, monitor KPIs and drive continuous improvement across cost and scalability.

Skills

Medical device manufacturing

Hardware operations

External manufacturing partners

ISO 13485 familiarity

Cross-functional collaboration

Regulatory awareness

Education

Master's degree in Mechanical/Biomedical/Electrical/Industrial Engineering

Tools

BOM management

Documentation control

ISO 13485 quality systems

Job description

MindAffect is seeking a Senior Medical Device Manufacturing Engineer to lead the establishment and scaling of the Sofi production platform. You will own manufacturing readiness, partner onboarding, and governance in CE MDR and FDA contexts, ensuring transfer from development to regulated production.

You will subsequently manage the operational backbone, including supply chain, production oversight, and lifecycle support, with potential for broader leadership roles as the company scales.