Mechanical Engineering Manager

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.

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

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.

• ◆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.

• ✓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.