Principal Engineer, Disposables

Responsibilities

• Lead and execute verification and validation (V&V) activities for medical device disposables to ensure compliance with customer, safety, and regulatory requirements.
• Drive test automation and implement creative solutions to enhance productivity and quality in test deliverables.
• Partner with cross-functional R&D teams to coordinate integration and system testing.
• Plan, build, and maintain test infrastructure and manage laboratory budget planning.
• Execute IQ, OQ, and PQ for equipment and instruments in accordance with QMS site policies.
• Manage laboratory qualification and vendor qualification processes to ensure equipment is fit for intended use.
• Design and develop test fixtures by preparing technical drawings and collaborating with external vendors.
• Lead and drive the closure of non-conformances (NCs) or findings identified during corporate, internal, or regulatory audits.

Requirements

• Bachelor's or Master's degree in Mechanical Engineering or a relevant technical field.
• 9 to 14 years of experience in Systems and Component level Verification & Validation (V&V).
• Deep domain knowledge in the design verification and validation of medical devices.
• Technical testing or reliability experience with plastics, connectors, or electro-mechanical products.
• Strong understanding of hardware methodologies and industry-standard test best practices.

Preferred Qualifications

• Hands-on experience with mechanical equipment such as UTM, Leak Testers, and Torque Testers.
• Exposure to medical device regulatory standards and manufacturing processes (e.g., RF welding, solvent bonding).
• Proficiency with statistical analysis tools like Minitab and Six Sigma methodologies.

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 dedicated to elevating the dialysis experience through digital solutions and advanced services while investing in the future of vital organ therapies.