Engineer II, Lab Testing

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.

About Vantive

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 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 portfolio focused on Lab testing and administration. You will have an independent responsibility to plan and execute formal V&V testing of Acute Disposables compliant to all the requirements, state-of-the-art methods and standards. Candidate needs to work with R&D engineers to help build Test fixtures/assemblies and assisting with Lab logistics. The candidate will also be a part of Lab Management team to ensure the Laboratory controls are in place in line with applicable international standards and guidelines. You will be expected to support and contribute to the Projects/Initiatives involving Lab testing for Product quality issues, root cause analysis, Test Method development, verification & validation, Design of Experiments testing.

Essential Duties and Responsibilities:

• 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.
• Follow QMS, ensure good documentation and Good Manufacturing practices are followed in the Verification Process.
• 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

• Diploma or Bachelor's Degree in Mechanical engineering / Biomedical Engineering / Polymer Engineering Related disciplines of Engineering
• Overall 4 to 10 yrs of Industry experience with minimum 2 years in Medical Device Verification testing [Mechanical Hardware/Disposables].
• Experience in Lab Management and establishing Laboratory controls in line with International Standards regulations [FDA].
• Experience in developing the Procedures and Processes for Engineering labs and Testing facilities. Relevant technical testing/reliability experience in electro-mechanical devices.
• Identify and report any quality or compliance concerns and take immediate corrective / Preventive action as needed
• An understanding of test methods and processes as well as the methods used to verify product in the realms of; mechanical, functional, and environmental testing environments.
• Experience in medical device or similar product development, design verification/validation, system integration (involving software & hardware), risk management, reliability engineering, process validation
• Quality systems Basic understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards.
• Experience in facing internal/External Audits.
• Self-motivated, Good stakeholder management and effective communication skills.

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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