Eng II, Disposables

About the Role

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

Key Responsibilities

• Development of mechanical Fluid control systems by designing and conducting research programs; applying principles of mechanics, thermodynamics, hydraulics, heat transfer, and materials.
• Ensures successful integration of mechanical design entities with electrical and consumable components.
• Contributes to troubleshooting and problem solving efforts related to mechanical aspects of the design and interfaces with other design constituents.
• Contributes to development and documentation of mechanical systems architectures.
• Able to effectively transition products to manufacturing and ensure robust products and manufacturing processes.
• Generates and/or improves Plastic Component/System designs that are optimized for production, reliability, regulatory compliance, and cost.
• Performs in-depth mechanical engineering analysis and calculations, Risk Analysis.
• Resolves competing constraints between interrelated functions (engineering, purchasing, manufacturing, regulatory, marketing, etc.) required to deliver the product to market.
• Defines protocols and conducts necessary testing to validate the safety and effectiveness of the design(s).
• Develops and maintains an effective and corroborative working relationship with internal and external development partners.
• Executes protocols and testing required to validate the safety and effectiveness of the design(s).
• Troubleshooting and problem solving efforts related to mechanical aspects of devices and associated systems/subsystems.
• Creates and communicates design/test plans, tasks, deliverables, and status.
• Manages time and resources to meet committed schedule milestones.

Requirements & Tech Stack

• Demonstrated track record in Plastic component Design, preferably medical devices or other highly regulated products.
• In-depth knowledge of the regulatory environment for Design, Develop, and Manufacture of Medical products.
• Knowledge of machinery to build prototypes, handle a variety of materials for prototypes and testing (metals, plastics, films, etc.).
• Knowledge of machinery to 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 required.