Jobid=618559968020272601 (0.0198)
ppbSenior Medical Device Manufacturing Engineer /b /p pbAbout MindAffect /b /p pMindAffect is a Dutch health-tech company developing the next generation of brain-response-based sensory diagnostics. /p pMillions 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. /p pMindAffect is building a new approach to hearing diagnostics that removes this barrier. /p pOur 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. /p pMindAffect’s technology is now transitioning from advanced RD into scalable manufacturing, and we are looking for a Senior Medical Device Engineer to lead production of this system. /p pbPurpose of the Role /b /p pMindAffect is seeking an experienced Senior Medical Device Engineer to build and own the manufacturing and operational foundation behind Sofi®. /p pThis is a pivotal role for someone who has experience taking a medical device from late RD into regulated production environments (ISO 13485) and enjoys bridging engineering, manufacturing, and operational execution. /p pIn the first phase, you will focus on selecting and onboarding the right manufacturing partner and successfully transferring the Sofi design into scalable production. /p pIn the second phase, you will own the operational backbone of the product, including supply chain, production oversight, logistics, and lifecycle support. /p pAs 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. /p h3Responsibilities /h3 pbPhase 1 – Build Manufacturing Operational Readiness /b /p ul liLead the evaluation, selection, and onboarding of external manufacturing partners /li liConduct technical, operational, and quality due diligence on potential manufacturing partners /li liLead the design transfer from the current development partner to the chosen production manufacturer /li liDefine the manufacturing strategy and partner responsibilities within CE MDR and FDA frameworks /li liAct as MindAffect’s internal authority on manufacturability, industrialization, and production readiness /li liTranslate RD outputs into production-ready deliverables, including: ul liBills of Materials (BOMs) /li liApproved supplier lists /li liAssembly instructions /li liCalibration and testing specifications /li liDevice Master Record (DMR) documentation /li /ul /li liDefine and implement assembly, verification, calibration, and release processes /li liEstablish serialization, traceability, and Device History Record (DHR) processes aligned with ISO 13485 /li liDraft and implement Supplier Agreements, Quality Agreements, and operational SOPs /li liWork closely with engineering teams to determine which elements of the design must be optimized for scalable production /li /ul pPhase 2 – Run Manufacturing, Supply Chain Operations /p pOnce manufacturing is established, you will oversee the operational lifecycle of the product: /p ul liManage day-to-day relationships with manufacturing partners, OEM suppliers, and key vendors /li liOwn production planning, purchasing, and supplier performance management /li liMaintain manufacturing documentation, traceability systems, and change-control processes /li liOversee quality and reliability monitoring for production hardware /li liDesign and implement repair, refurbishment, warranty, and RMA processes /li liEstablish operational infrastructure for order fulfillment, logistics, and distributor support /li liSupport the commercial team with operational execution and product delivery /li liMonitor operational KPIs including cost, reliability, service levels, and warranty exposure /li liDrive continuous improvement across manufacturing quality, scalability, and cost /li /ul h3Requirements /h3 pbMust Have /b /p ul li5+ years of experience in medical device manufacturing or hardware operations in Europe /li liHands‑on experience bringing hardware-software medical devices from development into production /li liProven experience working with external manufacturing partners or OEMs /li liStrong familiarity with ISO 13485 environments /li liMaster’s degree in Mechanical Engineering, Electrical Engineering, Biomedical Engineering, Industrial Engineering, or similar /li liExperience establishing manufacturing processes, documentation, and production readiness /li liUnderstanding of manufacturing and assembly processes for PCB‑based electronics, complex enclosures, connectors, and cables. /li liAbility to work cross‑functionally with RD, regulatory, quality, and external partners /li /ul pbNice to Have /b /p ul liExperience with EEG systems, biosignal devices, sensors, audio electronics, or wearable hardware /li liKnowledge of manufacturing traceability systems, including Device History Records (DHR), serialization, and device tracking /li liBackground in early‑stage medical device companies transitioning from development to production /li liExposure to international distribution models, logistics operations, or distributor‑based commercialization /li /ul h3Why Join MindAffect /h3 ul liPlay a central role in transitioning a breakthrough neurotechnology device into global production /li liTake ownership of the entire manufacturing and operational backbone of the company /li liWork with a mission‑driven team tackling globally significant healthcare challenges /li liEnjoy a role with real responsibility, visibility, and long‑term leadership potential /li /ul /p #J-18808-Ljbffr
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