About Vantive
Job Description
You will be supporting the team responsible for developing solutions to challenging issues associated with the design, development, and sustenance engineering for our new and existing Disposables for the Acute Therapies product portfolio. You will be expected to support and contribute to the Projects/Initiatives involving Engineering change management, solutions for Product quality issues, root cause analysis, NCR handling, CAPAs, verification & validation, design transfer, Value improvement programs and Regulatory compliance activities. The successful candidate will possess solid hands-on technical abilities, an excitement and energy for product development, and a passion for their work and the impact it has on meeting the needs of patients.
Essential Duties and Responsibilities:
- Supports the R&D development and sustenance activities to execute global cross functional projects relating to Acute Therapies Disposables.
- Should have good understanding of principles of mechanics, thermodynamics, hydraulics, heat transfer, and materials to support development and sustenance activities of mechanical and Fluid flow systems involving injection molded components and soft tubing.
- Will work with senior members/SME of the team to carry out root cause analyses in case of product failures with minimal supervision
- Supports the R&D function to execute Lab testing activities relating to Acute Therapies Disposables.
- Support R&D engineers in Test fixture creation, Test set up readiness and test method validation
- Follow instructions and Test protocols with limited guidance from R&D engineers during Test execution.
- Support in Developing and Executing Test Procedures/Functional Requirements testing/Performance testing.
- Develop and Perform Design Verification & IQ/OQ/PQ where applicable.
- Will be responsible for project management activities which includes managing change controls tasks using Vantive s in-house tools like Trackwise8 and Team Center Unified.
- Will work with senior members/SME of the team for writing of verification/validation test, test cases and documenting results in the form of technical reports
- Able to design Plastic components with inputs from senior team member/SME.
- Support for Instrument Management and Calibration
- Support consumable management/Logistics/ Tracking of parts.
- Support Project execution support for tests involving Reliability equipment s and Thermal Chambers
- Follow safety guidelines and monitor the same for Lab operations.
- Trouble shoot unfavorable test outcomes and perform RCA.
- Works with external vendors for Transport validation, Stability, Sterilization tests, etc,, for Acute Disposables sets & accessories to define the test scope, author the test plans, test procedures, execute & consolidate the reports
- Collaborate with key stakeholders to resolve tests-related technical issues.
Education and Experience
- Graduate or Postgraduate in Mechanical Engineering/ Polymer Technology/Plastic Technology/Bio Medical engineering or Equivalent.
- Minimum 2 years of product life cycle experience.
- Prior experience of technical and project leadership in Sustenance/New product development in Medical device or other highly regulated industry
- Prior experience in Design and Development of Single use medical device is a plus.
Reasonable Accommodation