Mechanical Engineer IV

Summary

The Heart Failure R&D team in Burlington, MA is seeking a Senior Mechanical Engineer to lead the development of Mechanical Circulatory Support devices, particularly Left Ventricular Assist Devices (LVADs).

What You’ll Work On

• 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.

Preferred Qualifications

• Experience with Class III implantable devices or cardiovascular technologies.
• Familiarity with FDA regulations, EUMDR, ISO 13485, ISO 14971 design controls and regulatory requirements.
• Exposure to computational modeling, fluid dynamics, and hemocompatibility testing.
• Experience with cable design, electromechanical integration, and biocompatible materials.