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