Job Description

JOB DESCRIPTION:

·         Hand on experience in Medical Device Design & DHF Remediation documentation. 

·         Hands on experience latest developments in 3D design, capture and modeling tools and technologies.

·         Hands on experience working on Validation reports for the Manufacturing site that are moving from one place to another. This includes Facility Validation as well.

·         Working on sample size determination, creating sample size for Testing, for Design Verification, Validation, Process Validation and Test Method Validation.

·         Preferable to have knowledge of Risk Management Systems based on ISO 14971:2012.  

·         Experience in EU Medical Device Regulation (2017/745) & FDA 21 CFR part 820.

·         Understand Product BOMs and Assessment with reference to information available in PLM/Other Repository.

·         Working closely with multiple stakeholders and understanding their Requirements and working on collaborative mode. Understand the customer requirements and suggest alternative feasible concepts.

REGARDS

MOHAMMED ILYAS,

PH - 229-264-4029.

Additional Information

All your information will be kept confidential according to EEO guidelines.