Senior Mechanical Engineer - Medical Devices, Regulated Design

The Fountain Groups; Burlington (MA); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading medical device firm in the U.S. is seeking a Mechanical Engineer with over 6 years of experience in mechanical design and development. The ideal candidate will have a Bachelor's degree in Mechanical Engineering and demonstrate expertise in CAD design, specifically SolidWorks. Responsibilities include test method development and ensuring compliance with FDA regulations. Strong communication skills and experience with Class III implantable devices are essential.

Qualifications

• 6+ years of experience in mechanical design and development, mostly in the medical device industry.
• Strong understanding of materials, manufacturing processes, and design for reliability.
• Experience with Class III implantable devices or cardiovascular technologies.

Responsibilities

• Lead technical projects and deliver results in a regulated environment.
• Develop and execute test methods specifically with INSTRON or similar compression/tension testers.
• Ensure compliance with FDA regulations, EUMDR, ISO 13485, ISO 14971 design controls.

Skills

Test method development

CAD design and drawing

Mechanical design and development

Proficiency in SolidWorks

Excellent communication

Education

Bachelor’s degree in Mechanical Engineering or related STEM field

Tools

INSTRON

COMSOL

Job description

A leading medical device firm in the U.S. is seeking a Mechanical Engineer with over 6 years of experience in mechanical design and development. The ideal candidate will have a Bachelor's degree in Mechanical Engineering and demonstrate expertise in CAD design, specifically SolidWorks. Responsibilities include test method development and ensuring compliance with FDA regulations. Strong communication skills and experience with Class III implantable devices are essential.