Roles and Responsibilities
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.
PCB production documentation
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