We are seeking a Technical Documentation Engineer for a Global Medical Tech Solutions Provider. /n Job Profile: /n Active cooperation with the engineering team during medical device development to understand the product and manage production/post-production documentation. /n Hands-on device work to create product structures (BoM) and technical production documents: /n Product assembly and packaging instructions /n PCB production documentation /n Cable assembly documentation /n Guide the project team regarding incoming and outgoing inspection requirements. /n Create product labels with the Regulatory department and support Marketing with user manuals. /n Compile all medical product information into a Device Master Record (DMR) and lead design transfer to bridge the gap between Project Manager and Production Technologist. /n Manage engineering changes effectively as the gatekeeper of change quality. /n Drive continuous department improvement by sharing best practices and developing guidelines, work instructions, and checklists. /n Technical Documentation Engineer Requirements: /n Education:
Graduation or Diploma in Mechanical or Electrical Engineering. /n Technical Competencies: Ability to work independently, think technically, and analyze problems. /n Exposure to product design/process and production workflow/process. /n Engineering change management experience via ECR/ECO process. /n Ability to work with ERP tools like Helios to manage the product lifecycle from concept to end-of-life. /n Ability to create illustrations and assembly documentation using 3D CAD and graphics software. /n Proven experience in technical documentation creation. /n Passion for success, proactive initiative, clear/logical thinking, and deep attention to detail. /n Flexibility, hands-on attitude, willingness to learn current technologies, strong teamwork, and clear communication skills. /n Additional Expectation: /n Experience with graphics software such as CorelDraw. /n Experience with CAD software such as SolidWorks (Assembly module). /n Familiarity with ISO 13485 regulations and DHF/DMR remediation.