Senior Manager, Engineering Flexible Endoscopes and Charlton CoE Lead

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