Mechanical Engineer

Mechanical Engineer – Burlington, MA

Job Title: Mechanical Engineer

Location: Burlington, MA (100% ON‑SITE)

# SEDAA 46673

PAY RANGE: 100K – 110K/Annum

Our Heart Failure R&D team is seeking a Senior Mechanical Engineer to provide technical leadership and hands‑on expertise in the development of Mechanical Circulatory Support devices, specifically Left Ventricular Assist Devices (LVAD). This role is ideal for an engineer passionate about solving complex problems in life‑sustaining technologies and driving innovation in mechanical and electromechanical systems.

You will work cross‑functionally to design, analyze, prototype, and test implantable Class III devices, contributing to the full product lifecycle from concept through commercialization.

• Test method development and execution specifically with in INSTRON or similar compression/tension tester
• CAD design and drawing skills including GD&T
• Product development experience for medical device

• Specify, design, verify, and validate mechanical components and subsystems for LVADs in accordance with regulatory and quality standards.
• Apply empirical, numerical, and experimental analysis (FEA, CFD, etc.) to evaluate and optimize designs for performance, reliability, and manufacturability.
• Develop and execute test methods and simulation models to mitigate design risks and ensure product robustness.
• Lead design reviews, risk assessments, and documentation efforts including CAD models, specifications, and technical reports.
• Collaborate with cross‑functional teams including systems, electrical, software, clinical, and manufacturing engineering.
• Interface with suppliers and internal teams to source prototype and production components.
• Mentor junior engineers and contribute to a culture of technical excellence and continuous improvement.

• Bachelor’s degree in Mechanical Engineering or related STEM field.
• 6+ years of experience in mechanical design and development, preferably in the medical device industry.
• Proficiency in Solid Works or equivalent CAD software and FEA tools (e.g., COMSOL).
• Strong understanding of materials, manufacturing processes, and design for reliability.
• Demonstrated ability to lead technical projects and deliver results in a regulated environment.
• Excellent communication and documentation skills.

• Experience with Class III implantable devices or cardiovascular technologies.
• Familiarity with FDA regulations, EUMDR, ISO 13485, ISO 14971 design controls and regulatory requirements.
• Exposure to computational modeling, fluid dynamics, and hemocompatibility testing.
• Experience with cable design, electromechanical integration, and biocompatible materials.

Job Title: Mechanical Engineer

Location: Pleasanton, CA (100% ON‑SITE)

# SEDAA 43086

PAY RANGE: 50K – 90K/Annum

Performs complex activities in the testing and sustaining of class II and class III mechanical circulatory support products including Ventricular Assist Devices (VADs), extracorporeal blood pumps, and oxygenators. Provides technical solutions to a wide range of difficult problems. Exercises considerable latitude in determining technical objectives and solutions of assignments.

• Research, test, and sustain electromechanical devices for VAD applications
• Work with cross‑functional teams for development of new products, and improvement to existing products driven by corrective and preventative actions (CAPA)
• Use experimental, empirical, and numerical analysis to evaluate designs.
• Develop and qualify (IQ/OQ) fixtures/equipment for verification testing
• Investigate issues and identify root causes in complex systems where analysis of situations or data requires an in‑depth evaluation of various factors
• Identify and mitigate technical risks
• Create/review technical drawings for appropriate assembly, dimensioning, and tolerancing
• Knowledgeable in GD&T
• Able to review/create tolerance analysis of existing systems
• Understands complex machined parts, injection molded parts, extrusions, molding of silicone
• Wide range of assembly techniques (laser welding, ultrasonic welding, bonding, mechanical…