Senior Manager, Engineering Flexible Endoscopes and Charlton CoE Lead
Charlton, MA, US, 01507
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.
KARL STORZ is committed to maintaining a safe work environment for our employees and customers. Most field-based roles at KARL STORZ require hospital credentialing/health screens as a condition of employment. Credentialing can include required vaccinations, health screens & other requirements as outlined by our customers. During the interview process, we encourage you to ask how credentialing/health screens may impact the role you are seeking and if you require any reasonable accommodations regarding these requirements.
The pay range and/or hourly pay rate listed is a good faith determination of potential base compensation that may be offered to a successful applicant for this position at the time of this job posting and may be modified in the future. When determining a specific team member’s base salary and/or hourly pay rate, several factors will be considered including such things as location, specialty, service line, years of relevant experience, education, professional credentials, internal equity, and the amount budgeted for the role.
KARL STORZ is committed to creating an inclusive space where employees are valued for their skills and unique experiences. To achieve this goal, we are committed to diverse voices, and all applicants will receive consideration without regard to race, color, sex, national origin, disability, veteran status, or any other protected characteristic. KARL STORZ is also committed to providing reasonable accommodations during our recruitment process. Should you need assistance or accommodation please email us at taoperations@karlstorz.com.
Nearest Major Market: Worcester