Eng II, Disposables

About the Role

Vantive is seeking an Eng II, Disposables to develop creative solutions for challenging issues associated with the design, development, and sustaining engineering for its new and existing home dialysis product portfolio. The successful candidate will possess solid "hands-on" technical abilities, excitement and energy for product development, and a passion for their work and its impact on meeting patient needs.

Key Responsibilities

• Develop mechanical fluid control systems by designing and conducting research programs; applying principles of mechanics, thermodynamics, hydraulics, heat transfer, and materials.
• Ensure successful integration of mechanical design entities with electrical and consumable components.
• Contribute to troubleshooting and problem-solving efforts related to mechanical aspects of the design and interfaces with other design constituents.
• Contribute to the development and documentation of mechanical systems architectures.
• Effectively transition products to manufacturing and ensure robust products and manufacturing processes.
• Generate and/or improve plastic component/system designs optimized for production, reliability, regulatory compliance, and cost.
• Perform in-depth mechanical engineering analysis and calculations, and Risk Analysis.
• Resolve competing constraints between interrelated functions (engineering, purchasing, manufacturing, regulatory, marketing, etc.) required to deliver the product to market.
• Define protocols and conduct necessary testing to validate the safety and effectiveness of the design(s).
• Develop and maintain effective and collaborative working relationships with internal and external development partners.
• Execute protocols and testing required to validate the safety and effectiveness of the design(s).
• Address troubleshooting and problem-solving efforts related to mechanical aspects of devices and associated systems/subsystems.
• Create and communicate design/test plans, tasks, deliverables, and status.
• Manage time and resources to meet committed schedule milestones.

Requirements & Tech Stack

• Demonstrated track record in plastic component design, preferably in medical devices or other highly regulated products.
• In-depth knowledge of the regulatory environment for the design, development, and manufacture of medical products.
• Knowledge of machinery to build prototypes, handle a variety of materials for prototypes and testing (metals, plastics, films, etc.), and set up engineering tests to validate new products and processes.
• Demonstrated record of working with multiple vendors and suppliers.
• Knowledge of standards such as IEC 60601, UL, ANSI, ASTM.
• Experience working with regulatory bodies like UL, TuV, ITT.
• Understanding of the healthcare regulatory environment and country regulations.

Qualifications

• Demonstrated strong analytical and problem-solving skills.
• Excellent verbal and written communication skills.
• Success in working with multifunctional, global teams.
• Excellent interpersonal/communication/influencing skills.