Senior Medical Device Manufacturing Engineer, Ede

Senior Medical Device Manufacturing Engineer

About MindAffect

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 amuch 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 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

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