R&D Project Manager - LSI

R&D Project Manager - LSI at Vantive summary:

As an R&D Project Manager in the Lead System Integrator team at Vantive, you lead the management and technical leadership of projects involving medical device research and development. Your responsibilities include schedule creation and tracking, risk management, coordination across multiple R&D sites, and ensuring compliance with FDA, ISO, and IEC design controls. You contribute to advancing vital organ therapies by overseeing cross-functional teams, facilitating communication, and driving innovation from concept through system verification.

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

The Lead System Integrator (LSI) team is a part of the R&D organization that supports the design , development and sustenance of therapy devices. Within the team we provide project management activities in 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 and services to patients and continue Baxter’s mission to save and sustain lives.

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. 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.

Project Manager role leads R&D project teams with their Project Management and Technical Leadership skills.

What you will be doing

• Lead research and development (R&D) project management work and research for medical devices and regulated healthcare products

• Owner of R&D program schedule creation, tracking, and execution. Responsible for delivering an integrated product with detailed plans from primary iteration to successful system verification completion

• Participates as a member of cross functional teams and/or integrates cross functional inputs into project delivery

• Ensures identification and communication of project risks, development of risk plan and proactive management of risk response strategies

• 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

• Leads scheduled meetings in R&D, develops and manages agenda, creates minutes, and follows up action items throughout the integration steps

• Establish project communication channel.
  
  E.g., Teams group, Status meeting, Escalation matrix, etc.

• Facilitate/organize project design reviews and change control meetings

• Anticipates potential conflict situations for proactive solutions and manages conflict situations to result in win-win outcomes

What you will bring

• Bachelors degree in Engineering or equivalent field

• 7 + years of R&D experience; 5+ years project management experience

• Experience in medical device industry required

• Ability to manage cross-functional teams simultaneously in a matrix environment

• Detailed understanding of project management tools,…