Principal Mechanical Engineer

Responsibilities

• Lead the mechanical design, analysis, and integration of systems and sub-systems for vital organ therapy products.
• Generate and optimize electro-mechanical designs for production, reliability, and cost-effectiveness.
• Perform in-depth mechanical engineering calculations and resolve competing constraints between engineering, manufacturing, and regulatory functions.
• Transition products to manufacturing by ensuring robust processes and maintaining accurate DHF and DMR documentation.
• Execute testing protocols to validate the safety and effectiveness of designs.
• Lead troubleshooting and problem-solving efforts related to mechanical device aspects.
• Apply technical risk mitigation tools and execute strategies to ensure optimal product results.
• Participate in Design Review Teams and contribute to intellectual property initiatives.

Requirements

• Extensive experience in mechanical engineering analysis and design of complex systems.
• Strong knowledge of regulatory compliance standards, including FDA, ISO, and IEC.
• Proven expertise in managing DHF (Design History File) and DMR (Device Master Record) documentation.
• Proficiency in electro-mechanical design and integration.
• Experience using technical risk mitigation tools.
• Ability to work with regulatory bodies such as UL, TuV, or ITT.

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.