Senior Mechanical Engineer – LVAD & Heart Failure R&D

Stark Pharma Solutions Inc; Burlington (MA); On-site; USD 120,000 - 190,000; Full time

Job summary

Stark Pharma Solutions Inc in Burlington, MA seeks a Senior Mechanical Engineer to join Heart Failure R&D, focusing on Mechanical Circulatory Support devices. You will design, develop, and validate components for life-sustaining medical devices and drive projects from concept to commercialization.

The role requires hands-on CAD, FEA/CFD, and robust knowledge of materials and manufacturing processes. You will collaborate across disciplines and mentor junior engineers while ensuring regulatory

Qualifications

• Bachelor's degree in Mechanical Engineering or a related field.
• 6+ years of mechanical design and product development experience, preferably in medical devices.
• Hands-on testing experience using INSTRON or similar equipment.
• Strong CAD design experience with engineering drawings and GD&T.
• Experience supporting medical device product development projects.

Responsibilities

• Design, develop, verify, and validate mechanical components for implantable cardiovascular devices.
• Lead product development from concept through commercialization while ensuring regulatory compliance.
• Develop and execute mechanical test methods using INSTRON or similar systems.
• Create CAD models, drawings, and GD&T documentation using SolidWorks.
• Perform analyses (FEA/CFD) to optimize performance and reliability.
• Lead design reviews and prepare technical documentation and specifications.
• Collaborate with Systems, Electrical, Software, Clinical, Manufacturing, and Quality teams.
• Support prototype development, supplier interactions, and component sourcing.
• Mentor junior engineers and contribute to technical excellence.

Skills

Mechanical design

GD&T

Engineering drawing

FEA/CFD

Product development

Regulatory compliance

Education

Bachelor's degree in Mechanical Engineering

Tools

INSTRON testing

SolidWorks

Job description

Stark Pharma Solutions Inc in Burlington, MA seeks a Senior Mechanical Engineer to join Heart Failure R&D, focusing on Mechanical Circulatory Support devices. You will design, develop, and validate components for life-sustaining medical devices and drive projects from concept to commercialization.

The role requires hands-on CAD, FEA/CFD, and robust knowledge of materials and manufacturing processes. You will collaborate across disciplines and mentor junior engineers while ensuring regulatory