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 SolidWorks 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.
