Website:
btlnet.co.in
Job details:
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.
- 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
- Good communication skills & interpersonal skills.
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
Click on Apply to know more.
