**Key Responsibilities** 1. Overview management of Medical Devices development process as per specific product requirements and in line with respective country regulatory guidance 2. Generate technical documentation for the product Design History file and Device Master Records as per specific country regulatory guidance 3. To support Business in identifying New technologies /Device manufacturing partners and in evaluation of patents 4. Designing and Development of assembling and in-process testing machines 5. 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 6. To provide quality engineering support to commercial Medical Devices **Key Competencies and Attributes** 1. Demonstrable Detailed working knowledge of Medical Device Industry 2. Complete understanding of Drug Device Combination Products guidelines of specific countries 3. Thorough knowledge in various ISOs related to Medical Device Development , inprocess testing 4. Knowledge on Human Factor Testing and statistical analysis of data 5. Knowledge on various manufacturing and assembling process of Medical Devices including materials used in manufacturing of Medical Devices 6. Ability to establish good network in developing and execution of Medical Device Projects 7. Application knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing. 8. 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. 9. Technical knowledge to navigate complex agency regulations of FDA & QSR requirements and guidance under 21 CFR820, ISO13485 and ISO14971. 10. Should be creative , continually learning and exploring new ideas 11. Good team player who works well in a team with strong interpersonal skills , a demonstrated ability to influence his/her peers 12. Displays highest level of integrity and confidentiality We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.