|
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.
|