Job Summary
Job Title -Research Associate III
Location - Whitefield, Bangalore
Shift - General
Job Responsibilities:
- Act as Product Design Owner (PDO) within its product family and technical expert for projects in development and lifecycle management activities within R&D Kidney Care Solutions Development
- Organize, plan and execute sustaining activities in compliance with current QA/ environmental/ regulations and standards
- Provide technical leadership, mentor and guide the change owners and Project Leads within its product family in order to get tasks accomplished according to plans, milestones and business needs
- Responsible for development and delivery of plastic materials and mechanical testing, writing of verification test protocols, test cases and reports
- Troubleshooting, root-cause-analysis and problem-solving related to material aspects of the products associated with field performance and manufacturing
- Review and approve Design Control documentation for projects in development and sustaining activities.
- Responsible and accountable for the design history files of a given product family
- Establish, maintain and update technical specification describing product appearance, characteristics and functions, and associated verification and validation documents
- Organize, plan and follow the execution of product changes, supplier changes and labelling tasks related to life cycle management projects
- Support Product Risk Owners with the Design related information and associated failure modes and risks arising from any of the design changes for a given product family
- Support worldwide product registration and launch following international/regional/national regulations; provide technical support to authorities questions
- Provide technical leadership for products/process/cost improvements related to life cycle management projects
- Provide resource estimation and forecast
- Ensure good internal and cross-functional communication at a global front and regular status update of projects
Qualifications and Skills
- Masters in chemistry or Polymer science with at least 10 years of relevant experience or Ph.D. in relevant sciences discipline with at least 7 years of relevant experience.
- Excellent English verbal and written communication skills
- Exposure to medical devices and drug products
- Proficient with polymeric materials testing methodologies, such as, FTIR, GC-MS, HPLC, tensile testing etc
- Good knowledge of product development stages and life cycle management: development, stability, clinical, registration, process transfer, production, suppliers, customer service
- Good knowledge of Design Control documentation and process
- Prior experience of product design owner (PDO) / Material SME role for pharmaceutical products and medical devices
- Demonstrated project/program leadership in medical device / drug industry
- Exposure to Product Risk Management for medical devices and drug products
- Working knowledge of international/regional/national regulations and standards
- Experience in project management and stakeholder management at a global front
- Must be able to able to carry out strategy and vision set by upper management and be able to communicate the vision to more junior associates.
- Ability to work independently.
Equal Employment Opportunity
Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.