Senior Mechanical Engineer
Il y a 3 heures
Diepenbeek, Flanders, Belgique
Jobtailor
Temps plein
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pul liSupport the Chief Engineer with the design and development of invoX devices and associated manufacturing processes /li liProvide medical device design expertise for successful design, development, and verification of invoX devices /li liEstablish and maintain design controls according to invoX SOPs and relevant regulatory guidelines /li liEstablish and maintain version control for devices in development and post-design freeze /li liLead CAD and PDM software use, including drawing standards and version/release control /li liManage and execute proof-of-concept activities through analytical models, calculations, and empirical testing /li liApply analytical methods appropriate to project stage and required accuracy /li liAssess design intent of components and assemblies against manufacturing capability, quality, and cost /li liAnalyze requirements and design data to recommend suitable design solutions /li liCreate and tailor design reviews, presentations, and reports for manufacturers, managers, and clients /li liAuthor and review design inputs such as requirements and DFMEAs /li liAlign design outputs such as specifications, CAD, BOMs, and release notes for manufacturing partners /li liWrite reports and documentation to a high standard /li liProvide technical advice and troubleshoot issues using structured problem-solving tools such as 8D /li /ul h3Requirements /h3 ul liMaster in Mechanical Engineering /li liGood understanding of medical device standards and essential requirements /li liHands on with a robust design process, preferably ICH QbD related to CFR820 design controls /li liHands on risk management /li liExperience with design product DFMEA tools /li liHands on design for manufacture tools and techniques /li liExperience with aligning product DFMEA to process PFMEA tools /li liHands on CAD/CAE, preferably Creo /li liTolerance stack analysis and statistical tools; JMP preferred /li liMaterials expertise in medical-grade plastics, springs, and elastomers preferred /li liGood understanding of the English language, both written and spoken /li liComfortable working in different cultures /li liFlexible with a can-do and hands-on mentality /li liSelf-starter able to work autonomously /li liExcellent problem-solving skills /li liGood planning and organization skills /li liSix Sigma training desirable /li liTrack record with patent filing and/or patent management desirable /li liDetailed understanding of respiratory standards and regulatory requirements desirable /li liExperience with complex respiratory devices desirable /li /ul h3Core Competencies /h3 pDemonstrates expertise in medical device design and development, with a strong focus on regulatory compliance, design controls, and risk management. Proficient in CAD/CAE tools, particularly Creo, and experienced in applying analytical methods and statistical tools for product development. /p h3Highest-signal resume keywords /h3 ul liMaster In Mechanical Engineering /li liMedical Device Design Expertise /li liCAD/CAE Proficiency, Preferably Creo /li liDFMEA And PFMEA Alignment /li liHands On Risk Management /li /ul h3Hard Skills /h3 ul liDesign Controls /li liTolerance Stack Analysis /li liStatistical Tools /li liAnalytical Methods /li liProof-Of-Concept Activities /li liDesign For Manufacture Techniques /li liVersion Control /li liDFMEA Tools /li liEmpirical Testing /li liDocumentation Writing /li /ul h3Soft Skills /h3 ul liExcellent Problem-Solving Skills /li liGood Planning And Organization Skills /li liFlexible And Hands-On Mentality /li liSelf-Starter /li liComfortable Working In Different Cultures /li /ul h3Certifications Qualifications /h3 ul liSix Sigma Training /li /ul h3Industry Keywords /h3 ul liMedical Device Standards /li liCFR820 Design Controls /li liRespiratory Standards /li liPatent Filing /li liPatent Management /li /ul h3Tools Technologies /h3 ul liCAD Software /li liPDM Software /li liJMP /li li8D Problem-Solving Tools /li liMedical-Grade Plastics /li liSprings /li liElastomers /li /ul /p