R&D Engineering Manager

Company Overview:

Lexington Medical, Inc. is a medical device company developing and manufacturing minimally invasive surgical stapling solutions in the Boston area. With the highest standards in design engineering and smart manufacturing, our team delivers disruptive technology to healthcare providers, improving surgical outcomes for patients in a thriving $6B+ surgical stapler market.

Rooted in a talent-dense culture, we are committed to innovation, foster continuous growth, and achieve great heights together. At Lexington Medical, Inc., you will have the opportunity to impact the lives of millions of patients worldwide and thrive in a fast-growing Med Tech company.

Role Overview:

We are hiring an Engineering Manager to lead our R&D Handle team at Lexington Medical, Inc. in Bedford, MA. In this role, you will provide both technical and people leadership to a team of 3-5 engineers supporting our Powered and Manual Surgical Stapler platforms through all phases of product development, from active improvement programs to sustaining lifecycle activities.

Responsibilities:

• Lead and mentor a team of engineers in a fast-paced environment across sustaining and active product development programs, upholding high standards of execution and quality.
• Build and develop a high-performing team through performance management, career development, skill-building opportunities, recruiting, and onboarding.
• Participate in high-level product definition and design requirement decisions and translate these into actionable plans, managing priorities, timelines, and cross-functional goals and dependencies.
• Proactively identify and communicate resource gaps and project risks to leadership.
• Serve as a technical resource and escalation point; review and approve engineering documentation, change orders, and risk management files.
• Own the Design History File (DHF) and all other relevant product documentation (including transfer to production), ensuring documentation accuracy and compliance throughout development and design transfer.
• Collaborate cross-functionally with RA/QA, Supply Chain, and Operations to support product initiatives and process improvements.

Qualifications:

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, or a related field.
• 7+ years of product development experience; 2+ years leading development teams through complex technical projects; medical device experience is a plus.
• Must have led end-to-end project execution with full ownership of outcomes.
• Demonstrated ability to bring a product from initial concept development through transfer to production.
• Strong leadership skills with the ability to energize, empower, and unite a team in a common goal. Excellent time management skills with a proven ability to meet deadlines through a team. Ability to delegate and prioritize tasks.
• Excellent organizational skills and attention to detail. Strong problem-solving skills, including root cause analysis and critical thinking.
• Proficiency with Solid Works and strong first-principles mechanical engineering fundamentals.
• Experience with design controls and quality systems (such as ISO 13485) across all phases of development and sustaining.
• Experience with electromechanical devices a plus.

Location & Work Arrangement:

This position is based in Bedford, Massachusetts (near Boston) and is an onsite position.

Company Overview & Disclaimer:

Lexington Medical, Inc. is a surgical stapling company based in Bedford, MA, developing smart surgical technology for minimally invasive procedures. We're hiring top engineers and medical device sales professionals to help us grow and improve outcomes for patients worldwide.