Mechanical Engineering Manager - Medical Devices Lead & Deliver

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

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.