What are the responsibilities and job description for the Senior Mechanical Engineer position at Intellectt Inc?
Job Title : Senior Mechanical Engineer – Heart Failure R&D (LVAD)
Location: Burlington, MA (100% Onsite)
Duration: 12 Months Contract (Possible Extension)
Schedule: Monday–Friday | 8:00 AM – 5:00 PM | 40 Hours/Week
Summary
Seeking a Senior Mechanical Engineer to support the development of Mechanical Circulatory Support devices, including Left Ventricular Assist Devices (LVADs). This role involves mechanical design, analysis, prototyping, testing, and product development of Class III implantable medical devices in a regulated environment
Responsibilities
- Design, develop, verify, and validate mechanical components and subsystems for LVAD prod
- Perform engineering analyses including FEA, CFD, and experimental test
- Develop and execute test methods to evaluate product performance and reliabilty
- Create CAD models, drawings, specifications, and technical documentation
- Participate in design reviews, risk assessments, and design control activites
- Collaborate with cross-functional engineering and manufacturing t
- eSupport prototype builds, supplier interactions, and design transfer activites
- Provide technical leadership and mentoring to junior engineer
Required Qualifications
- Bachelor's degree in Mechanical Engineering or related STEM
- 6 years of mechanical design and product development experience
- Strong experience with SolidWorks (or equivalent CAD software) and FEA
- Knowledge of materials, manufacturing processes, and design for reliabi
- Experience working in regulated product development environment
- Excellent communication and technical documentation skills
Preferred Qualifications
- Experience with Class III implantable medical devices or cardiovascular products
- Knowledge of FDA, ISO 13485, ISO 14971, and EU MDR requirements
- Experience with CFD, computational modeling, hemocompatibility testing, or electromechanical systems