Specify, design, verify, and validate mechanical components and subsystems for LVADs in accordance with regulatory and quality standards.
Apply empirical, numerical, and experimental analysis (FEA, CFD, etc.) to evaluate and optimize designs for performance, reliability, and manufacturability.
Develop and execute test methods and simulation models to mitigate design risks and ensure product robustness.
Lead design reviews, risk assessments, and documentation efforts including CAD models, specifications, and technical reports.
Collaborate with cross-functional teams including systems, electrical, software, clinical, and manufacturing engineering.
Interface with suppliers and internal teams to source prototype and production components.
Mentor junior engineers and contribute to a culture of technical excellence and continuous improvement.
Required Qualifications:
Bachelor’s degree in Mechanical Engineering or related STEM field.
6+ years of experience in mechanical design and development, preferably in the medical device industry.
Proficiency in SolidWorks or equivalent CAD software and FEA tools (e.g., COMSOL).
Strong understanding of materials, manufacturing processes, and design for reliability.
Demonstrated ability to lead technical projects and deliver results in a regulated environment.
Excellent communication and documentation skills.
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