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Senior Manager, Engineering Flexible Endoscopes and Charlton CoE Lead (Charlton, MA, US, 01507) @ Karl Storz SE & Co. KG

Charlton, Massachusetts, USOnsiteFull-time
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About this role

<h2><span><strong>About the Role</strong></span></h2> <p><strong>Senior Manager, Engineering – Flexible Endoscopes &amp; Charlton CoE Lead</strong></p> <p>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&amp;D, production, and product management.</p> <h2><span><strong>Key Responsibilities</strong></span></h2> <ul> <li>Lead design, development, testing, and manufacturing transition of flexible endoscope products</li> <li>Manage complex R&amp;D projects, ensuring delivery on time and within budget</li> <li>Oversee product improvements, upgrades, and cost reduction initiatives</li> <li>Ensure compliance with FDA, ISO, and internal quality standards</li> <li>Provide leadership, coaching, and development for engineering team members</li> <li>Collaborate cross-functionally with production, technical teams, and product line management</li> <li>Serve as Charlton CoE Lead, including oversight of electronics and sterilization leads</li> <li>Act as site lead and audit contact for US R&amp;D operations</li> <li>Support risk management activities to ensure safe and compliant product releases</li> </ul> <h2><span><strong>Requirements</strong></span></h2> <ul> <li>Bachelor’s degree in Mechanical Engineering (or related field)</li> <li>8+ years of experience in medical device product development</li> <li>Strong proficiency in SOLIDWORKS and CAD tools</li> <li>Experience with FDA QSR, ISO 13485 / 9001, and regulated environments</li> <li>Proven experience leading technical teams and cross-functional projects</li> <li>Strong project management, problem-solving, and analytical skills</li> </ul> <h2><span><strong>Nice to Have</strong></span></h2> <ul> <li>Experience leading international teams</li> <li>Background in endoscopic or complex medical device systems</li> <li>Advanced experience with product lifecycle documentation and audits</li> </ul> <h2><span><strong>What You&apos;ll Need to Succeed</strong></span></h2> <ul> <li>Strong leadership and team development capabilities</li> <li>Ability to build consensus across multidisciplinary teams</li> <li>Excellent communication and presentation skills</li> <li>Detail-oriented with a proactive, self-directed approach</li> <li>Ability to navigate ambiguity and drive technical decision-making</li> </ul> <h2><span><strong>What We Offer</strong></span></h2> <ul> <li>Opportunity to lead cutting-edge medical device innovation</li> <li>Collaborative, cross-functional R&amp;D environment</li> <li>Exposure to global engineering teams and projects</li> <li>Career growth within a leading MedTech organization</li> </ul> <h2><span><strong>KARL STORZ Company Overview</strong></span></h2> <p>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.</p>

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