Senior Manager, Engineering Flexible Endoscopes and Charlton CoE Lead

About the Role

Senior Manager, Engineering – Flexible Endoscopes & Charlton CoE Lead

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.

Key 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

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 Have

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

What You'll Need to Succeed

• Strong leadership and team development capabilities
• Ability to build consensus across multidisciplinary teams
• Excellent communication and presentation skills
• Detail-oriented with a proactive, self-directed approach
• Ability to navigate ambiguity and drive technical decision-making

What We Offer

• Opportunity to lead cutting-edge medical device innovation
• Collaborative, cross-functional R&D environment
• Exposure to global engineering teams and projects
• Career growth within a leading MedTech organization

KARL STORZ Company Overview

KARL STORZ is a global leader in endoscopic technology, delivering innovative medical solutions that improve patient outcomes. As a family-owned company, KARL STORZ combines a legacy of precision engineering with a commitment to advancing minimally invasive care worldwide.