Lexingtonmedical

Mechanical Engineering Manager

Bedford, MA. Posted a month ago

The role

You will lead a team of 3 to 5 mechanical and product engineers designing surgical staplers from concept to production. You will manage technical project execution and own the Design History File and design control documentation.

What you will do

  • Lead, hire, and develop a team of 3 to 5 mechanical and product engineers
  • Run day-to-day technical project execution
  • Own the Design History File and related design control documentation
  • Participate in product definition and design requirement decisions
  • Lead design reviews and review engineering work for technical accuracy
  • Guide the team through root cause analysis and problem solving
  • Support product initiatives driven by RA/QA, Supply Chain, and Operations
  • Partner with Manufacturing, Quality, and commercial teams

Required qualifications

  • Bachelor's degree in mechanical engineering, electrical engineering, or a related engineering discipline
  • 8+ years of overall experience, including leading development teams through complex technical projects
  • Proven experience managing or mentoring engineers
  • Led at least one project end to end with full ownership of the outcome
  • Demonstrated experience bringing a product from initial concept development through transfer to production
  • Strong grasp of design controls and Design History File ownership in a regulated environment
  • Strong communication and problem-solving skills, including root cause analysis and analytical thinking
  • Ability to prioritize, delegate, and hit deadlines through a team

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. Their AEON(TM) Endoscopic stapler is an FDA-cleared, minimally invasive surgical stapler used in operating rooms around the world.

Mechanical Engineering Manager at Lexingtonmedical | JobZoey