About the Role
We are seeking a Senior Mechanical Engineer to join our Heart Failure R&D team. This position involves providing technical leadership and hands-on expertise in the development of Mechanical Circulatory Support devices, specifically Left Ventricular Assist Devices (LVAD). The role is ideal for an engineer passionate about solving complex problems in life-sustaining technologies and driving innovation in mechanical and electromechanical systems. You will work cross-functionally to design, analyze, prototype, and test implantable Class III devices, contributing to the full product lifecycle from concept through commercialization.
Pay - $60/hr - $65/hr
Responsibilities
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.
Education Qualification*
Required Skills*
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.
Experience with test method development and execution, specifically with INSTRON or similar compression/tension tester.
CAD design and drawing skills including GD&T.
Product development experience for medical devices.
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.
The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually as applicable.
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