Senior Medical Device Manufacturing Engineer

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 a Dutch health-tech company developing the next generation of brain-response-based sensory diagnostics.

Millions of children, elderly people, and individuals with disabilities cannot be reliably tested with today’s hearing assessments, which depend on subjective responses such as pressing a button when a sound is heard. When hearing loss goes undetected, the consequences can include lifelong challenges in language development, cognition, and social interaction.

MindAffect is building a new approach to hearing diagnostics that removes this barrier.

Our technology has received international recognition, including the Innovation Prize at the World Congress of Audiology. We measure how the brain responds to sound, enabling objective hearing assessment without requiring a behavioral response from the patient. At the core of this innovation is Sofi®, a system currently being prepared for regulatory approval that integrates a proprietary EEG headset, a combined EEG/audio amplifier, and our Rapid-CAEP® analysis technology into one platform. The result is a portable and easy-to-use system designed to bring high-quality hearing diagnostics to a much broader range of environments: from hospitals and audiology clinics to retail settings, schools, and community health programs.

MindAffect’s technology is now transitioning from advanced R&D into scalable manufacturing, and we are looking for a Senior Medical Device Manufacturing Engineer to lead production of this system.

Purpose of the Role

MindAffect is seeking an experienced Senior Medical Device Engineer to build and own the manufacturing and operational foundation behind Sofi®.

This is a pivotal role for someone who has experience taking a medical device from late R&D into regulated production environments (ISO 13485) and enjoys bridging engineering, manufacturing, and operational execution.

In the first phase, you will focus on selecting and onboarding the right manufacturing partner and successfully transferring the Sofi design into scalable production.

In the second phase, you will own the operational backbone of the product, including supply chain, production oversight, logistics, and lifecycle support.

As the company grows, this role can naturally evolve into a broader operations leadership position (e.g., Chief Production Officer / COO-type role), becoming the internal authority on everything related to the physical product and its production.

Responsibilities

Phase 1 - Build Manufacturing & Operational Readiness

• Lead the evaluation, selection, and onboarding of external manufacturing partners
• Conduct technical, operational, and quality due diligence on potential manufacturing partners
• Lead the design transfer from the current development partner to the chosen production manufacturer
• Define the manufacturing strategy and partner responsibilities within CE MDR and FDA frameworks
• Act as MindAffect’s internal authority on manufacturability, industrialization, and production readiness
• Translate R&D outputs into production-ready deliverables, including:

• Bills of Materials (BOMs)
• Approved supplier lists
• Assembly instructions
• Calibration and testing specifications
• Device Master Record (DMR) documentation

• Define and implement assembly, verification, calibration, and release processes
• Establish serialization, traceability, and Device History Record (DHR) processes aligned with ISO 13485
• Draft and implement Supplier Agreements, Quality Agreements, and operational SOPs
• Work closely with engineering teams to determine which elements of the design must be optimized for scalable production

Phase 2 - Run Manufacturing, Supply Chain & Operations

Once manufacturing is established, you will oversee the operational lifecycle of the product:

• Manage day-to-day relationships with manufacturing partners, OEM suppliers, and key vendors
• Own production planning, purchasing, and supplier performance management
• Maintain manufacturing documentation, traceability systems, and change-control processes
• Oversee quality and reliability monitoring for production hardware
• Design and implement repair, refurbishment, warranty, and RMA processes
• Establish operational infrastructure for order fulfillment, logistics, and distributor support
• Support the commercial team with operational execution and product delivery
• Monitor operational KPIs including cost, reliability, service levels, and warranty exposure
• Drive continuous improvement across manufacturing quality, scalability, and cost

Requirements

Must Have

• 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

Nice to Have

• Experience with EEG systems, biosignal devices, sensors, audio electronics, or wearable hardware
• Knowledge of manufacturing traceability systems, including Device History Records (DHR), serialization, and device tracking
• Background in early-stage medical device companies transitioning from development to production
• Exposure to international distribution models, logistics operations, or distributor-based commercialization

Why Join MindAffect

• Play a central role in transitioning a breakthrough neurotechnology device into global production
• Take ownership of the entire manufacturing and operational backbone of the company
• Work with a mission-driven team tackling globally significant healthcare challenges
• Enjoy a role with real responsibility, visibility, and long-term leadership potential