Senior Mechanical Engineer

As a Senior Mechanical Engineer at Lexington Medical, you will work on the mechanical design of AEON surgical stapling instruments in Bedford, MA while mentoring a team of talented engineers. You will stay hands-on in mechanism design, guide mechanical and product engineers through real projects, and own the work from first requirements to updating the Design History File.  This mentoring role is designed to grow into managing the team directly.

About Lexington Medical

Lexington Medical is a medical device company designing and manufacturing surgical stapling technology at our headquarters in Bedford, Massachusetts, just outside Boston. Our AEON Endoscopic Stapler is an FDA-cleared, minimally invasive surgical stapler used in operating rooms around the world. With engineering, manufacturing, and quality working closely together, engineers stay close to the product and see their work move from an idea through prototyping, testing, manufacturing, and ultimately into the operating room.

About the Role

As a Senior Mechanical Engineer at Lexington Medical, you will be a senior technical voice and mentor for mechanical and product engineers working on our AEON surgical stapling instruments. You will carry products through the full development lifecycle: new product development, design for manufacturability and other DFX improvements, transfer to production, and sustaining changes after launch. You will own meaningful design work yourself, from CAD and tolerance analysis through prototyping and bench testing, while helping the engineers around you sharpen their technical skills.

This role has a deliberate path into people management. You will start by mentoring the group, reviewing their designs, and coaching them through their projects. Because R&D, manufacturing, quality, regulatory, and supply chain all work in the same Bedford building, you will partner with those teams directly and see the results of your decisions on the production floor.

Responsibilities

• Design mechanisms and subsystems critical to product function and safety, applying your expertise in CAD, GD&T, tolerance stack-ups, prototyping, and bench testing.
• Lead design reviews, ensuring that designs account for manufacturing, quality, regulatory, and clinical requirements.
• Turn product definition and design requirements into project plans for new products, product improvements, and DFX changes, and help the team track schedules and clear roadblocks.
• Mentor mechanical and product engineers through design reviews, project management, and day-to-day technical guidance.
• Exercise ownership over significant portions of the Design History File and design control documentation under our quality system (21 CFR 820 and ISO 13485).
• Guide engineers through root cause analysis and problem solving on design issues, from prototype and verification testing through production.
• Take ownership of team development by participating in interviewing and hiring. Grow into individual goal setting, and performance management.
• Partner with RA/QA, Supply Chain, Operations, and Manufacturing design changes for supplier transitions, CAPAs, cost and yield improvements, and new product launches.

Qualifications

• Bachelor’s degree in mechanical engineering or 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, problem-solving skills, with attention to detail.
• Experience with electromechanical medical devices is a plus.

What Success Looks Like

• By 3 to 6 months: you are a trusted mentor and technical reference for the group, you run design reviews the team finds useful, you have built working relationships with each engineer and your cross-functional partners.
• By 6 to 12 months: you have stepped into, or are clearly on track for, managing the team, which is consistently meeting its commitments, and at least one product improvement or new product has moved forward on schedule under your guidance.
• What makes someone excellent: they stay technically sharp enough to challenge a design, give engineers room to own their work, and catch cross-functional problems before they reach production.

Location & Work Arrangement

This position is based at our headquarters in Bedford, Massachusetts, in the Greater Boston area, and is an on-site role.