Senior Manager R&D, Systems Engineering

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

We are seeking a highly motivated and experienced Senior R&D Manager to lead the System Engineering team for our Acute Renal Therapies portfolio. The successful candidate will play a critical role in the development of life-sustaining medical devices used in critical care environments, including continuous renal replacement therapy (CRRT) systems. This leadership position will focus on cross-disciplinary system integration, design control, requirements management, and risk analysis to deliver safe, effective, and regulatory-compliant products. 

What You'll Be Doing

• Lead and mentor a team of system engineers responsible for the architecture, integration, and performance and design history file of acute renal therapy systems. 

• Oversee systems engineering processes, including requirements development, traceability, interface definition, system modeling, and design verification and validation. 

• Collaborate with cross-functional teams (Mechanical, Electrical, Software, Clinical, Regulatory, Quality, and Manufacturing) to ensure successful end-to-end product development. 

• Lead technical reviews and decision-making across the product lifecycle, from concept through commercialization. 

• Support regulatory submissions and responses by generating high-quality documentation and system-level justifications. 

• Champion continuous improvement of systems engineering practices and tools across the R&D organization. 

• Stay abreast of industry trends, standards, and technologies relevant to extracorporeal therapies and critical care devices. 

• Set policies for staff in accomplishing and documenting projects 

• Takes accountability for resource staffing and project execution with proactive management of technical and project risk to ensure delivery of business commitments. 

Qualifications: 

• Bachelor’s or Master’s degree in Systems Engineering, Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related discipline; advanced degree preferred. 

• 8+ years of experience in medical device development, with at least 3 years in a technical leadership or people management role. 

• Solid understanding of requirements creation, definition, testability, and traceability through the verification and validation process 

• Demonstrated expertise in systems engineering for complex electromechanical medical devices; experience in renal or critical care therapies is strongly preferred. 

• In-depth knowledge of design control, product risk management, and regulatory standards (e.g., IEC 60601, ISO 13485, ISO 14971, FDA QSR, MDR). 

• Proven track record of leading successful product development programs from concept to market launch. 

Preferred Skills