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