R&D Project Leader II – LSI

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.

Vantive: A New Company Built on Our Legacy

Since last year, Baxter has been on a journey to separate our Kidney Care segment into a standalone company. Vantive will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. 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 are driven to help improve patients’ lives worldwide. Join us as we revolutionize kidney care and other vital organ support.

Summary:

The Lead System Integrator (LSI) team is a part of the R&D organization that supports the Kidney Care business segment. Within the team, we provide R&D focused project management support for all product phases, innovation initiatives, new product development and improvement programs for existing therapy systems.

Vantive is a global company with R&D sites at multiple locations in the world; competences and capabilities are spread over the different R&D sites, and you will commonly collaborate with colleagues across several of these R&D sites and with other functional representatives. Work assignments within the team are highly variable and we can promise you a work environment with exciting project management challenges and variability in your day-to-day activities.

The Kidney Care R&D - Drug Products and Sciences (DPS) organization is responsible for Kidney Care drug products (dialysis solutions, concentrates, etc) and related sciences (Sterility Assurance, Analytical Chemistry, materials compliance, Extractables & Leachables, Toxicology). As a member of the Drug Products and Sciences organization, the Lead System Integrator co-ordinates/leads DPS R&D activities within a Project or Program with her/his Project Management and Technical Leadership skills. This role may be responsible for supporting multiple projects.

Essential Duties and Responsibilities.  This section contains a list of five to eight primary responsibilities of the work.  The incumbent will perform other duties as assigned.

• Lead research and development (R&D) project management work for drug products, medical devices, and other regulated healthcare products
• Owner of R&D program schedule creation, tracking, and execution. Integrate inputs from all DPS competencies/subject matter experts into a harmonized project proposal, project schedule, technical risk assessment, and other project plans.
• Participates as a member of cross functional teams and/or integrates cross functional inputs into project deliverables
• Accountable for project execution and proactive risk management.  Effectively tracks project status, risks, budget, and external spend.
• Demonstrates understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards
• Prepares project reports, analyses and delivers presentations to R&D leadership on a regular basis
• Leads scheduled meetings in R&D, develops and manages agenda, creates minutes, and follows up action items throughout the project
• Establish project communication channels and archives. e.g., Teams group, Status meetings, Escalation matrix, etc. 
• Facilitate/organize DPS R&D project design reviews and change control meetings 
• Facilitate purchase orders (POs) and approve corresponding invoices for the R&D tasks executed by external vendors (e.g., external labs, translation agencies, etc.)  
• Across multiple parallel projects, identify and evaluate interactions/dependencies and potential synergy opportunities

Qualifications.  To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.  List knowledge, skills, and/or abilities required. 

• Experience in project management principles and methodologies
• Strong interpersonal and communication skills in written and verbal form
• Demonstrated ability to draw conclusions and make recommendations based on technical inputs from multiple and varied functions (Marketing, Quality, Regulatory, etc.).
• Ability to provide technical leadership and coordination for medical product projects with substantial complexity and scope.
• Ability to decompose complex problems into actionable plans and track them to closure
• Understanding of design requirements for development, validation, and verification of medical products

Education and/or Experience.  Include the education and/or experience that is necessary to perform the job satisfactorily.

• Bachelors degree in Engineering, Science or related field
• 10+ years of relevant R&D, Project management (or similar) experience preferred
• Experience in pharmaceuticals or medical product industry preferred

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

Recruitment Fraud Notice

Vantive has discovered incidents of employment scams, where fraudulent parties pose as Vantive employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.