Mechanical Engineering Manager

Lexington Medical, Inc; Bedford (MA); On-site; USD 125,000 - 175,000; Full time

Job summary

Lexington Medical, Inc. is seeking a Mechanical Engineering Manager in Bedford, MA to lead a small team of mechanical and product engineers from concept through production.

You will own the Design History File and drive cross-functional collaboration with R&D, manufacturing, quality, regulatory, and supply chain in a on-site setting. You will oversee project plans, reviews, and documentation to ensure compliant development and timely product launches of AEON surgical stapling instruments.

Qualifications

• 8+ years of overall experience 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 through transfer to production.
• Strong grasp of design controls and Design History File ownership in a regulated environment.

Responsibilities

• Lead, hire, and develop a team of 3 to 5 mechanical and product engineers, setting clear expectations and managing performance.
• Run day-to-day technical project execution: remove roadblocks, resolve resource conflicts, and maintain schedules.
• Own the Design History File and related design control documentation, including design transfer to production, per 21 CFR 820 and ISO 13485.
• Translate product definitions into detailed project plans for new products, improvements, and DFX changes.
• Lead design reviews and ensure technical accuracy with manufacturing, quality, regulatory, and clinical considerations.
• Guide root cause analysis and problem solving from prototype through production.
• Support RA/QA, Supply Chain, and Operations on design changes, CAPAs, and cost/yield improvements.
• Partner with Manufacturing, Quality, and commercial teams to drive product improvements and launches.

Skills

Team leadership

Project management

Mechanical engineering

Design controls

Root cause analysis

Communication

Education

Bachelor's degree in mechanical engineering

Job description

As a Mechanical Engineering Manager at Lexington Medical, you will lead a team of mechanical and product engineers designing surgical staplers from concept to production. You will help shape how the team plans, reviews, and delivers its work while staying close to the engineering itself. The instruments your team designs move from CAD and bench testing into operating rooms, and you will own that path from the first requirements to the Design History File.

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(TM) 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 Mechanical Engineering Manager at Lexington Medical, you will provide people leadership and technical project management for a team of 3 to 5 engineers working on our AEON(TM) surgical stapling instruments. Your team 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 sit in the rooms where product definition and design requirements are decided, then turn those decisions into project plans your team can execute. Because R&D, manufacturing, quality, regulatory, and supply chain all work in the same Bedford building, you will partner with those teams directly rather than through layers of process, and you will be accountable for the design controls and documentation that keep our products compliant.

Responsibilities

• Lead, hire, and develop a team of 3 to 5 mechanical and product engineers, setting clear expectations, giving direct feedback, and managing performance.
• Run day-to-day technical project execution: clear roadblocks, resolve resource conflicts, and hold the team to its commitments and schedules.
• Own the Design History File and related design control documentation for your products, including design transfer to production, in compliance with our quality system (21 CFR 820 and ISO 13485).
• Participate in high-level product definition and design requirement decisions and translate them into detailed project plans for new products, product improvements, and DFX changes.
• Lead design reviews and review engineering work for technical accuracy, making sure designs account for manufacturing, quality, regulatory, and clinical requirements.
• Guide the team through root cause analysis and problem solving on design issues, from prototype and verification testing through production.
• Support product initiatives driven by RA/QA, Supply Chain, and Operations, such as design changes for supplier transitions, CAPAs, and cost or yield improvements.
• Partner with Manufacturing, Quality, and commercial teams to drive product improvements and new product launches.

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, with close attention to detail.
• Ability to prioritize, delegate, and hit deadlines through a team while keeping people energized and aligned on a shared goal.
• Experience with electromechanical medical devices, surgical instruments, or Class II devices is a plus.

What Success Looks Like

• By 3 to 6 months: you have built working relationships with each engineer and your cross-functional partners, taken ownership of your team's project plans and DHF, and have run design reviews the team finds useful.
• By 1 year: your team is consistently delivering on its commitments, you have hired or grown engineers who raise the team's bar, and at least one product improvement or new product has moved forward on schedule under your leadership.
• 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.

Visit our Candidate Journey page to learn what to expect from our hiring process.

Salary Range: $125,000 USD - $175,000 USD