- Develop and improve product quality of Spine Instrument & customise tools.
- Create and Develop Concepts of Instruments which are useful in enabling technology of Spinesurgery.
- Work independently on designactivities from Concept stage.
- Understand spec. requirement, convert requirements to technical spec and develop alternate/ customise concepts for spine instruments & tools.
- Product development and Reverse engineeringusing CADsoftware PRO-E Tool Design etc.
- Design and detailing products at components and subsystem level using CADtool and PDM link.
- Design and development and Testing of spine implant instruments using CAD.
- Medical Image Segmentation and anatomical measurements.
- Review research articles/patents.
- Appropriate material Selection for alpha Design.
- Design and development of Integrated Medical Device.
- Design development using 3D Printing Technology.
- Review new productdesigns to identify & forecast issues, by application of advanced predictive engineering principles and ensure all the parts go together.
- Draft & design drawings, New Product Design (NPD), Value engineering, reverse engineering of given products, fixtures, assemblies on various software platforms, like solid works etc.
- Ensure compliance to various applicable internal procedures and international standards and guidelines for design and development activities such as ISO 13485, CFR etc.
- Coordinate with other departments relating to Design and New Product Development.
Desired Candidate Profile Desired Candidate Skills and Qualifications:
- BE/ B.Tech Mechanical with 4+ Year experience in Design & Development for spineimplements,Spinetools and spine Custom tools etc.
- Hands on experience in AutoCAD, Solid works, MS-Office etc.
- Knowledge of U.S. FDA medical device regulations and standard requirements (ISO 13485/ ISO 9001, ISO 14971, DHF, FMEA, EU Medical Device Directive will be an add on.
- Experience in mechanical characterisation of cadaver samples will be of advantage.
- Experience in 3D Printing Technology (DMLS/SLA/SLS/FDM).
- Experience in fabrication of implant design using microwave sintering process will be of advantage.
- Experience on concept development, prototyping and testing.
- Should have good understanding of Ideation process and design.
- Hand-on experience on concept prototyping, testing.
- Ability to implement USFDA and ISO 13485 design control requirements.
- Strong competencies in Project planning, Quality Check and on time Projects Delivery.
- Support release of drawings and documentation.
- Creative mind set to create tool interface which adds additional degree of freedom to surgical system.
Role:Senior Design Engineer
Salary: 6,00,000 - 10,00,000 P.A.
Industry:Medical Devices & Equipment
Role Category:Engineering Design
Employment Type:Full Time, Permanent
UG:B.Tech/B.E. in Biomedical, Mechanical
PG:Post Graduation Not Required
Doctorate:Doctorate Not Required
Bee5 Manpower Consulting