R&D Project Leader II – LSI

Vantive: A New Company Built On Our Legacy

nBaxter is on a journey to separate our $5B 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.

nAt Vantive, you will become part of a community of people who are focused, courageous and dont 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.

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  nCompletion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.

nSummary:

nThe 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. This collaborative role gives you the direct opportunity to define solutions to new products challenges and services to patients and continue Baxters mission to save and sustain lives.

nBaxter 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.

nThe 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.n

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.

• nLead research and development (R&D) project management work for drug products, medical devices, and other regulated healthcare products
• nOwner 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.
• nParticipates as a member of cross functional teams and/or integrates cross functional inputs into project deliverables
• nAccountable for project execution and proactive risk management. Effectively tracks project status, risks, budget, and external spend.
• nDemonstrates understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards
• nPrepares project reports, analyses and delivers presentations to R&D leadership on a regular basis
• nLeads scheduled meetings in R&D, develops and manages agenda, creates minutes, and follows up action items throughout the project
• nEstablish project communication channels and archives. e.g., Teams group, Status meetings, Escalation matrix, etc.
• nFacilitate/organize DPS R&D project design reviews and change control meetings
• nFacilitate purchase orders (POs) and approve corresponding invoices for the R&D tasks executed by external vendors (e.g., external labs, translation agencies, etc.)
• nAcross multiple parallel projects, identify and evaluate interactions/dependencies and potential synergy opportunities

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

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

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

• nBachelors degree in Engineering, Science or related field
• n10+ years of relevant R&, project management experience
• npreferred
• nExperience in pharmaceuticals or medical product industry preferred

nReasonable Accommodations
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nBaxter 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.

nRecruitment Fraud Notice
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nBaxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter 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.