Senior Manager, Engineering Flexible Endoscopes and Charlton CoE Lead

KARL STORZ•Charlton, MA

About The Position

This role leads the KARL STORZ Development Engineering group focused on flexible endoscopic products, overseeing design, development, and lifecycle management. The position ensures high-quality product design, compliance with standards, and successful execution from concept through production, while also serving as a key liaison across R&D, production, and product management.

Requirements

Bachelor’s degree in Mechanical Engineering (or related field)
8+ years of experience in medical device product development
Strong proficiency in SOLIDWORKS and CAD tools
Experience with FDA QSR, ISO 13485 / 9001, and regulated environments
Proven experience leading technical teams and cross-functional projects
Strong project management, problem-solving, and analytical skills

Nice To Haves

Experience leading international teams
Background in endoscopic or complex medical device systems
Advanced experience with product lifecycle documentation and audits

Responsibilities

Lead design, development, testing, and manufacturing transition of flexible endoscope products
Manage complex R&D projects, ensuring delivery on time and within budget
Oversee product improvements, upgrades, and cost reduction initiatives
Ensure compliance with FDA, ISO, and internal quality standards
Provide leadership, coaching, and development for engineering team members
Collaborate cross-functionally with production, technical teams, and product line management
Serve as Charlton CoE Lead, including oversight of electronics and sterilization leads
Act as site lead and audit contact for US R&D operations
Support risk management activities to ensure safe and compliant product releases