Research Associate Iii

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients— that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don’t settle for the mediocre. Each of us is driven to help improve patients’ lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

**Job Summary**
- **Job Title -Research Associate III**:

- **Location - Whitefield, Bangalore**:

- **Shift - General**

**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**:

- Master's 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.

**Reasonable Accommodation**

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