Job Description

Key Responsibilities
Overview management of Medical Devices development process as per specific product requirements and in line with respective country regulatory guidance
Generate technical documentation for the product Design History file and Device Master Records as per specific country regulatory guidance
To support Business in identifying New technologies /Device manufacturing partners and in evaluation of patents
Designing and Development of assembling and in-process testing machines
To Partner with Manufacturing ,Engineering /Projects , Quality team to ensure that the transition of products through R&D , Product approval and manufacturing scale up are smooth , timely and cost effective
To provide quality engineering support to commercial Medical Devices
Key Competencies and Attributes
Demonstrable Detailed working knowledge of Medical Device Industry
Complete understanding of " Drug Device Combination Products " guidelines of specific countries
Thorough knowledge in various ISO's related to Medical Device Development , inprocess testing
Knowledge on Human Factor Testing and statistical analysis of data
Knowledge on various manufacturing and assembling process of Medical Devices including materials used in manufacturing of Medical Devices
Ability to establish good network in developing and execution of Medical Device Projects
Application knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing.
Ability to utilizes quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings.
Technical knowledge to navigate complex agency regulations of FDA & QSR requirements and guidance under 21 CFR820, ISO13485 and ISO14971.
Should be creative , continually learning and exploring new ideas
Good team player who works well in a team with strong interpersonal skills , a demonstrated ability to influence his/her peers
Displays highest level of integrity and confidentiality
Qualification
An Engineering BE/ME - Mech
A minimum of 15-18 years in Medical Device environment with at least 5 years in Pharma Medical Device R&D Dept.

Skills Required