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Senior Manager, Engineering Flexible Endoscopes and Charlton CoE Lead

KARL STORZ Endovision Inc

Charlton, MA

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JOB DETAILS
SKILLS
Analysis Skills, Budget Management, CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), Category Management, Coaching, Communication Skills, Consensus Building Skills, Cost Control, Cross-Functional, Detail Oriented, Electronics, Engineering Management, FDA (Food and Drug Administration), ISO (International Organization for Standardization), ISO 9001, Leadership, Maintain Compliance, Manufacturing, Mechanical Engineering, Medical Equipment, Medical Products, Patient Care, Presentation/Verbal Skills, Problem Solving Skills, Product Design, Product Development, Product Documentation, Product Lifecycle, Product Management, Project/Program Management, Quality Metrics, Quality System Requirements (QSR), Regulatory Compliance, Remote Team Management, Research & Development (R&D), Risk Management, SolidWorks, Sterilization, Team Building, Team Lead/Manager, Team Player, Technical Delivery, Technical Leadership, Test Plan/Schedule, Time Management
LOCATION
Charlton, MA
POSTED
30+ days ago

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 Youll 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.

About the Company

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KARL STORZ Endovision Inc