Mechanical Engineer - Medical devices

Hiring for Senior Mechanical Engineer – R&D in Burlington, MA

Seeking a highly motivated Senior Mechanical Engineer to provide technical leadership and hands‑on expertise in the development of Mechanical Circulatory Support (MCS) devices, specifically Left Ventricular Assist Devices (LVADs).

• Lead and contribute to the design and development of implantable Class III medical devices
• Design, analyze, prototype, and test mechanical and electromechanical systems for LVAD platforms
• Develop and execute mechanical test methods, including compression and tension testing
• Collaborate cross‑functionally with R&D, Quality, Regulatory, Manufacturing, and Clinical teams
• Generate detailed CAD models and engineering drawings with proper GD&T application
• Support verification and validation activities, including documentation and regulatory compliance
• Drive continuous improvement and innovation within the Heart Failure product portfolio

• Test Method Development & Execution
• Experience developing and executing mechanical test methods
• Hands‑on experience with Instron or similar compression/tension testing systems
• CAD Design & GD&T
• Strong 3D CAD modeling and detailed drawing creation
• Proficient in Geometric Dimensioning & Tolerancing (GD&T)
• Medical Device Product Development
• Experience supporting the full product lifecycle
• Prior experience with implantable or Class III medical devices preferred

• Experience with Mechanical Circulatory Support systems
• Understanding of regulatory requirements for implantable medical devices
• Experience in risk management and design controls
• Strong analytical and problem‑solving skills
• Excellent communication and cross‑functional collaboration skills