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—this is what Vantive aspires to deliver.
We believe Vantive will not only build our leadership in the kidney care space but 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 mediocrity. 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
The Lead System Integrator (LSI) team is part of the R&D organization supporting the Kidney Care business segment. We provide R&D-focused project management support across all product phases, innovation initiatives, new product development, and improvement programs for existing therapy systems. This collaborative role offers the opportunity to define solutions to new product challenges and services for patients, continuing Vantive's mission.
Organization Context
The Kidney Care R&D - Drug Products and Sciences (DPS) organization handles kidney care drug products (dialysis solutions, concentrates, etc.) and related sciences (Sterility Assurance, Analytical Chemistry, materials compliance, Extractables & Leachables, Toxicology). As a member of this organization, the Project Manager leads DPS R&D project activities, utilizing project management and technical leadership skills. Responsibilities include forming project teams and developing effective operating mechanisms, often managing multiple complex or high-visibility projects simultaneously.
Key Responsibilities
1. Lead R&D project management efforts and facilitate technical decision-making for drug products, medical devices, and other regulated healthcare products.
2. Own the creation, tracking, and execution of R&D program schedules. Integrate inputs from all DPS competencies into harmonized project proposals, schedules, risk assessments, and plans.
3. Drive interactions and resolve technical issues with R&D functions and cross-functional teams for complex projects.
4. Participate as a member of cross-functional teams and incorporate their inputs into project deliverables.
5. Ensure project execution aligns with timelines, budgets, and risk management strategies.
6. Adhere to FDA, ISO, and IEC design control procedures, regulations, and standards.
7. Prepare reports and analyses, and deliver presentations to R&D leadership regularly.
8. Lead meetings, develop agendas, record minutes, and follow up on action items.
9. Establish communication channels and document archives (e.g., Teams groups, status meetings, escalation matrices).
10. Facilitate design reviews and decision meetings within R&D.
11. Manage purchase orders and approve invoices related to external vendors.
12. Identify and evaluate interactions, dependencies, and potential synergies across multiple projects.
Qualifications
1. Deep experience in project management principles and successful product development cycles.
2. Strong interpersonal and communication skills, both written and verbal.
3. Ability to synthesize technical inputs from diverse functions and make informed recommendations.
4. Technical leadership skills for complex medical product projects.
5. Proficiency in decomposing complex problems into actionable plans and tracking progress.
6. Understanding of development, validation, and verification requirements for medical products.
Education and Experience
* Bachelor's degree in Engineering, Science, or a related field.
* At least 7 years of R&D experience and 5 years in project management.
* Experience in pharmaceuticals or medical devices is strongly preferred.
Vantive supports workplace flexibility, including a minimum of 3 days onsite per week, to foster collaboration and community engagement.
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