Mechanical Engineer - Medical devices

Intellectt Inc; Burlington (MA); On-site; USD 80,000 - 120,000; Full time

Job summary

A leading medical device company is seeking a Senior Mechanical Engineer in Burlington, MA, to lead the design and development of LVADs. The role involves hands-on expertise in mechanical test methods and CAD design, ensuring compliance with regulatory standards. Candidates should have experience with medical device product development and the ability to work collaboratively within cross-functional teams. Strong problem-solving skills and communication abilities are essential as they drive innovation and continuous improvement in the Heart Failure product portfolio.

Qualifications

• At least 5 years of experience in mechanical engineering with a focus on medical devices.
• Hands-on experience with developing mechanical test methods.
• Proficient in 3D CAD modeling and GD&T.

Responsibilities

• Lead the design and development of Class III medical devices.
• Develop and execute mechanical test methods for LVAD platforms.
• Collaborate with cross-functional teams for product verification and validation.

Skills

Test Method Development & Execution

CAD Design & GD&T

Medical Device Product Development

Tools

Instron or similar testing systems

Job description

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).

Key Responsibilities

• 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

Top 3 Required Skills / Experience

• 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

Preferred Qualifications

• 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