Technical Documentation Engineer

BTL India Private Ltd; Bengaluru; On-site; INR 550,000 - 750,000; Full time

Job summary

BTL India Private Ltd in Bengaluru is seeking an Engineering Documentation Specialist to support medical device production. You will collaborate with the engineering team to develop product structures, BoMs, and production documents, ensuring compliance throughout the lifecycle.

You will manage ECN/ECO processes, work with Helios ERP, create CAD illustrations in SolidWorks, and prepare labels, manuals, and DMR data, bridging the gap between Project Manager and Production technologist while

Job description

As an integral part of the R&D team & trusted partner for production, the employee should be able to perform following (but not limited to) duties to support the team’s goals:

• Active Corporation with the engineering team during the development of medical devices, understand the product that is being developed & manage its production & post production documentation.
• Be hands on with the device & create product structure (BoM), technical production documents not limited to
• Product assembly & packaging instructions.
• Cable assembly documentation.
• Guide the project team w.r.t incoming & outgoing inspection requirements.
• Creation of product labels in collaboration with the Regulatory department & support to marketing in User manuals.
• Put together all the information about the Medical product in a DMR & be the key player in the design transfer bridging the gap between Project Manager & Production technologist.
• Manage the engineering changes effectively & be the gatekeeper of quality of changes.
• Strive for continuous improvement in the department by sharing best practices & developing guidelines/work instruction/checklist.

Essential QUALIFICATION AND EXPERIENCE

QUALIFICATION:

• Graduation/ Diploma in Mechanical or Electrical engineering.
• Technical competency:
• Ability to work independently, think technically & analytically.
• Exposure to Product design/process
• Exposure to Production workflow/process
• Engineering change management process via ECR/ECO process.
• Ability to work with ERP tools like Helios to create & maintain the life cycle of the product from evolution to end of life.
• Ability to create illustrations & assembly documentation for production using 3D CAD softwares & graphics softwares.
• Experience in creating technical documentation

BEHAVIOURAL competency:

• Passion for success & being proactive. You won't just wait for someone to hand you information; you will actively find out what production needs to run smoothly.
• Clear & logical thinking- Clear understanding of the purpose of the documentation that is prepared- Going in depth.
• Flexible, hands-on and willing to learn new technologies.
• Good team player with good collaboration skills.
• Eye for detail: Looking for perfection & attention to details

Additional QUALIFICATION AND EXPERIENCE

• Experience in working with Graphics software such as Corel Draw.
• Experience in CAD software such as Solidworks (Assembly module)
• Awareness of ISO 13485, DHF/DMR remediation will be added advantage