Senior Engineer, Acute Disposables

Responsibilities

• Support the design, development, and lifecycle management of complex disposable medical devices and sub-systems within the Acute Therapies portfolio.
• Define and drive product testing strategies, including the development of test plans, protocols, and reports to validate safety and effectiveness.
• Translate user, customer, and clinical needs into actionable design inputs and engineering requirements.
• Lead problem-solving activities using structured engineering tools and provide technical risk identification and mitigation.
• Create and maintain critical design documentation, including specifications, verification reports, Bill of Materials, and detailed engineering drawings for the Design History File (DHF).
• Collaborate with cross-functional teams including Quality, Regulatory, Manufacturing, and R&D to ensure successful product integration and transition to manufacturing.
• Manage the integration of deliverables from sub-system design teams and external partners.

Requirements

• Graduate or Postgraduate degree in Mechanical, Polymer, Plastic, or Bio-Medical engineering (or a closely related field).
• Minimum of 5 years of experience in product life cycle management.
• Proven experience in technical or project leadership within highly regulated industries (e.g., Medical Devices).
• Strong technical foundation in mechanics, thermodynamics, heat transfer, fluid flow, and materials/plastic technology.
• In-depth knowledge of FDA, ISO, and IEC design control processes and medical device regulatory frameworks.
• Experience with engineering change management, verification, and validation processes.

Preferred Qualifications

• Prior experience specifically in the design and development of single-use medical devices.
• Experience in sustaining engineering and value improvement projects.

About the Company

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. With a 70-year legacy of innovation in kidney care, we are expanding our expertise into digital solutions and advanced therapies to transform the patient experience worldwide.