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.

Your Role:

This role is aligned within the Kidney care Solutions and the Containers Team reporting to the Sr. Manager, Solutions and Containers team in the USA. As part of the Product Development Lifecycle Management and Sustaining Product Organization team you will play a key role in defining, organizing, planning, and leading global multi-functional projects related to all the modalities of Kidney care (PD, HD and Acute). You will work on new product development projects and innovative technologies supporting improving our products, therapies, and patient outcomes. You will propose options and develop action plans for problem-solving and product and process improvements.

This position will work on projects mainly associated with Acute kidney care solution and container products and will be responsible for all aspects of lifecycle management.

What You’ll Be Doing:

1. Define, organize, plan, and execute activities related to new product registration and product design changes in compliance with current international/regional/national regulations.
2. Support product lifecycle management and Sustenance organization in the area of medical devices and drug products.
3. Provide technical assessment and strategy for product changes related to design, labeling, raw material, manufacturing support, regulatory compliance, quality improvement, and new registrations.
4. Propose options and develop action plan for problem-solving, product and process improvement.
5. Participate in multi-functional and international project team for effective collaboration and deliverables.
6. Coordinate and ensure follow-up of technical activities in collaboration with customers, partners, and team members with respect to project dedication, quality procedures, and business needs.
7. Work with regulatory standards and quality management systems in the field of drug products, medical devices, and related areas.
8. Provide technical support to authorities’ questions in due time.
9. Establish, maintain, and update technical & design documentation according to Good Documentation Practices.
10. Ensure good internal and cross-functional communication and regular status update of activities.
11. Anticipate risks/challenges and willingness to help lead ambiguity.
12. Provide mentorship to newer members of the team.

What You’ll Bring:

1. PhD (preferred) or Masters (required) in Material Science, Materials Engineering, Polymer Chemistry, Polymer Engineering, Chemical Engineering, Biosciences, Biomedical Engineering, or related field.
2. Minimum of 10 years of diverse industrial experience in the given technical domains.
3. Broad understanding of the overall product and therapy along with deep technical expertise in one or more fields related to drugs, drug products, and/or medical devices.
4. Proven knowledge in the development of polymer materials, including expertise in multi-layer composites with sound knowledge of structure property relationships of polymers/materials.
5. Exposure to material characterization tools, focusing on extractables and leachables (E&L) and REACH compliant materials for drug products/medical devices.
6. Experience with the development, characterization, and process optimizations for new materials.
7. Knowledgeable with ICH, FDA, relevant cGxPs, ISO, and quality systems associated with pharmaceutical and medical devices development.
8. Understands the implications of raw material change in pharmaceutical and medical devices industries (product impact, process impact, regulatory implications, end user, sterilization, etc.).
9. Proven track record to create results within budget, timeline, and product/project work you're doing.
10. Knowledge of manufacturing processes and process optimizations for drug products/medical devices preferably in Parentals/combination devices space.
11. Possess an agile attitude.
12. Strong technical leadership and prior experience of leading multi-functional projects at a global front.
13. Expertise in Design Control documentation and medical writing.
14. Experience with Statistics and Six Sigma tools.
15. Experience with Trackwise, Digital Twin, and other quality tools of interest.
16. Experience with handling NCR, CAPA and other quality management systems.

Vantive is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

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, protected veteran status, disability/handicap status or any other legally protected characteristic.

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 let us know the nature of your request along with your contact information.