Job Description 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, explicit/logical thinking, and deep attention to detail.
n Flexibility, hands-on attitude, willingness to learn new 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.