Senior Mechanical Engineer

The role

You will design AEON surgical stapling instruments and mentor a team of mechanical and product engineers. You will stay hands-on in mechanism design and own work from first requirements to updating the Design History File.

What you will do

• Design mechanisms and subsystems critical to product function and safety, using CAD, GD&T, tolerance stack-ups, prototyping and bench testing.
• Lead design reviews that account for manufacturing, quality, regulatory and clinical requirements.
• Turn product definition and design requirements into project plans for new products, improvements and DFX changes.
• Mentor mechanical and product engineers through design reviews, project management and day-to-day technical guidance.
• Own significant portions of the Design History File and design control documentation under 21 CFR 820 and ISO 13485.
• Guide engineers through root cause analysis and problem solving from prototype and verification testing through production.
• Take part in interviewing and hiring, and in individual goal setting and performance management.
• Partner with RA/QA, Supply Chain, Operations and Manufacturing on supplier transitions, CAPAs, cost and yield improvements and product launches.

Required qualifications

• Bachelor's degree in mechanical engineering or a related engineering discipline.
• 4+ years of mechanical design experience in product development.
• Proficiency in CAD, GD&T, tolerance analysis and DFX principles.
• Demonstrated experience bringing a product from concept development through transfer to production.
• Working knowledge of design controls and Design History File documentation in a regulated environment.
• Experience mentoring or guiding other engineers, formally or informally, and a genuine interest in moving into people management.
• Experience as a technical or project lead on at least one complex project, with ownership of the technical outcome.
• Strong root cause analysis and problem-solving skills, with attention to detail.

Nice to have

• Experience with electromechanical medical devices, surgical instruments or Class II devices.

About the company

Lexington Medical is a medical device company designing and manufacturing surgical stapling technology at its headquarters in Bedford, Massachusetts. Its AEON Endoscopic Stapler is an FDA-cleared, minimally invasive surgical stapler used in operating rooms around the world.