Mechanical Engineer

Domain: Medical Devices – Mechanical Circulatory Support (Heart Failure R&D)

Requirements:

• Bachelor’s degree in Mechanical Engineering or related field.

• 6+ years of mechanical design experience in the medical device industry.

• Hands-on experience with INSTRON-based mechanical testing.

• Strong proficiency in SolidWorks and GD&T.

• Experience with FEA and design for reliability.

• Background working in regulated environments with strong technical documentation skills.

Key Responsibilities:

• Design and develop mechanical components and subsystems for LVAD products.

• Perform mechanical testing (compression/tensile) using INSTRON or similar systems.

• Conduct engineering analysis, including FEA (and CFD where applicable).

• Create detailed CAD models and drawings (SolidWorks, GD&T).

• Lead design reviews, risk assessments (FMEA), and verification/validation activities.

• Collaborate with cross-functional R&D, manufacturing, quality, and supplier teams.

• Ensure compliance with FDA and ISO 13485 standards.

Benefits:

• 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, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable).