Senior Mechanical Engineer

Il y a 5 heures

Diepenbeek, Flanders, Belgique Jobtailor Temps plein

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Support the Chief Engineer with the design and development of invoX devices and associated manufacturing processes Provide medical device design expertise for successful design, development, and verification of invoX devices Establish and maintain design controls according to invoX SOPs and relevant regulatory guidelines Establish and maintain version control for devices in development and post-design freeze Lead CAD and PDM software use, including drawing standards and version/release control Manage and execute proof-of-concept activities through analytical models, calculations, and empirical testing Apply analytical methods appropriate to project stage and required accuracy Assess design intent of components and assemblies against manufacturing capability, quality, and cost Analyze requirements and design data to recommend suitable design solutions Create and tailor design reviews, presentations, and reports for manufacturers, managers, and clients Author and review design inputs such as requirements and DFMEAs Align design outputs such as specifications, CAD, BOMs, and release notes for manufacturing partners Write reports and documentation to a high standard Provide technical advice and troubleshoot issues using structured problem-solving tools such as 8D Requirements

Master in Mechanical Engineering Good understanding of medical device standards and essential requirements Hands on with a robust design process, preferably ICH QbD related to CFR820 design controls Hands on risk management Experience with design product DFMEA tools Hands on design for manufacture tools and techniques Experience with aligning product DFMEA to process PFMEA tools Hands on CAD/CAE, preferably Creo Tolerance stack analysis and statistical tools; JMP preferred Materials expertise in medical-grade plastics, springs, and elastomers preferred Good understanding of the English language, both written and spoken Comfortable working in different cultures Flexible with a can-do and hands-on mentality Self-starter able to work autonomously Excellent problem-solving skills Good planning and organization skills Six Sigma training desirable Track record with patent filing and/or patent management desirable Detailed understanding of respiratory standards and regulatory requirements desirable Experience with complex respiratory devices desirable Core Competencies

Demonstrates 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. Highest-signal resume keywords

Master In Mechanical Engineering Medical Device Design Expertise CAD/CAE Proficiency, Preferably Creo DFMEA And PFMEA Alignment Hands On Risk Management Hard Skills

Design Controls Tolerance Stack Analysis Statistical Tools Analytical Methods Proof-Of-Concept Activities Design For Manufacture Techniques Version Control DFMEA Tools Empirical Testing Documentation Writing Soft Skills

Excellent Problem-Solving Skills Good Planning And Organization Skills Flexible And Hands-On Mentality Self-Starter Comfortable Working In Different Cultures Certifications & Qualifications

Six Sigma Training Industry Keywords

Medical Device Standards CFR820 Design Controls Respiratory Standards Patent Filing Patent Management Tools & Technologies

CAD Software PDM Software JMP 8D Problem-Solving Tools Medical-Grade Plastics Springs Elastomers

Senior Mechanical Engineer

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