Japan - Higashimurayama: Mechanical Engineer

Job Title: Mechanical Engineer (Medical Device Design) Location: Higashimurayama, Japan Position Type: Full-Time Contract (Direct Placement / Project Deployment) Openings: 1 Position Available Experience Required: 3 to 6 Years Payment Terms: 105 Days Net Replacement Terms: 90 Days --- About the Project & Opportunity Our UK-based international recruitment agency is managing a specialized hardware engineering deployment project for a leading medical technology organization in Higashimurayama, Japan. We are actively seeking one (1) skilled Mechanical Engineer to join the development team. This project centers on the design, validation, and regulatory compliance of high precision medical devices, offering an exceptional opportunity for a product development engineer to drive sustainability and safety initiatives in a world class manufacturing setting. What You Will Do - Execute the mechanical design of complex medical devices, creating detailed component designs, assembly configurations, and production ready CAD drawings. - Develop, compile, and maintain rigorous design outputs and Design History Files (DHF) in absolute compliance with ISO 13485 Quality Management Systems (QMS). - Lead sustainability activities and circular design initiatives across the medical products and healthcare portfolio. - Evaluate mechanical architectures against strict international compliance standards, ensuring systems meet IEC general safety requirements and the European Medical Device Regulation (MDR). - Take proactive initiative from project kickoff through to final production handover, working cross-functionally to resolve technical roadblocks. What We Are Looking For (Compliance & Requirements) - Industry Experience: 3+ years of dedicated, hands-on experience in the structural and mechanical design of commercial medical devices. - Documentation & Quality: Proven experience creating design output and handling DHF workflows under ISO 13485 regulations. - Engineering Tools: Advanced proficiency in 3D CAD modeling software and the generation of precise geometric tolerance manufacturing drawings. - Regulatory Frameworks: Thorough, working knowledge of ISO 13485 QMS, IEC standards (General Safety, Product Specific Criteria, Guarantees), and European Medical Device Regulation (MDR) frameworks. - Project Attributes: A self starting technical lead with the capability to manage project milestones autonomously within structured quality timelines. Next Steps for Applicants As the managing recruitment partner, our international mobilization team will guide qualified candidates through engineering design portfolio reviews, compliance screening panels, and Japan immigration/visa processing.