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New Product Development Engineer + Medical Device

Keywords / Skills : iso 13485, new product development, design development, medical devices, FMEA, G D&T;, DFMEA, DFM

6 - 10 years
Posted: 2019-05-10

Software Engineer/ Programmer
Team Leader/ Technical Leader
Posted On
10th May 2019
Job Ref code
Job Description
Job Description:


Education - Bachelors degree in Mechanical Engineering or Bioengineering / Bio medical Engineering

In-depth understands on Medical Devices (Class I, IIa, IIb & III)
Knowledge on ISO 14971 Medical Devices Application of Risk Management to Medical Devices
Knowledge on ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes
Knowledge on regulatory requirements MDD 93/42/EEC/ New MDR regulations & US FDA 21 CFR 820
Knowledge on ISO 10993-Biological Evaluation
Basic knowledge on biomaterials (Metals, Polymers, Ceramics, Material Characterization techniques)
Good Clinical Practices (GCP) & Good laboratory practices
Knowledge on new product development lifecycle
Hands on experience in Design & Development of Electro Mechanical Products/Modules which includes verification and validation
Good Product knowledge and experience on Electro mechanical devices
General knowledge on various Medical devices
Hand on experience in FMEA, G D&T with Tolerance stack up analysis and Design documentation processes
Hands on experience in DFMEA and DFM. Expertise in all kind of manufacturing processes

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