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