KARL STORZ North America · 17 hours ago
Systems Engineer
Charlton, MA
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expKARL STORZ North America is an independent, family-owned company specializing in MedTech innovations. They are seeking an experienced Systems Engineer to lead the design and development of complex products, ensuring they meet customer and regulatory requirements through collaboration with cross-functional teams.
Medical Device
Responsibilities
Develop and maintain top-level system requirements and architecture
Lead system integration efforts and verification activities throughout the development lifecycle
Collaborate with stakeholders to understand user needs and ensure system performance
Perform trade-off studies and select optimal design approaches
Develop and execute plans for integration and testing of product components
Manage system configurations and ensure traceability between system requirements and verification testing
Provide sustaining support for existing product lines and participate in continuous improvement initiatives
Derive and maintain system requirements and architecture
Ensure seamless integration of components
Perform risk analysis and develop mitigation strategies
Define network and insulation diagrams
Track and review detailed design specifications
Perform system analysis and modeling to support trade-off studies
Determine methods for evaluating and communicating analytical results
Research and develop new technologies for future and existing products
Communicate with vendors for new technologies and components
Provide analysis and support for existing product lines
Recommend design changes and document system changes
Participate in continuous improvement teams to improve product quality, processes, and services
Qualification
Required
8+ years of relevant work experience in a regulated industry, with 5+ years in a Systems Engineer or similar role
BS, MS, or PhD in Electrical Engineering, Physics, Electrical Computer Engineering, Computer Science, or similar
Experience with product development lifecycle in a highly regulated industry
Solid understanding of software design methodology, safety methodologies, and microprocessor-controlled systems
Excellent communication, collaboration, and problem-solving skills
Preferred
9+ years of experience in medical systems product design or similar complex systems
Knowledge of medical device quality system regulations and standards
Experience with image acquisition systems, image processing techniques, and testing of complex systems
Strategic thinking, creativity, and mentoring skills
Benefits
Opportunity to work on complex and innovative products
Collaborative and dynamic work environment
Continuous learning and growth opportunities
Company
KARL STORZ North America
KARL STORZ North America is a leader in endoscopic technology and imaging solutions across virtually all surgical specialties.
1001-5000 employees
H1B Sponsorship
KARL STORZ North America has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (13)
2024 (10)
2023 (14)
2022 (6)
2021 (8)
2020 (10)
Funding
Current Stage
Late StageLeadership Team
Bethany Kucera
Senior Human Resources Business Partner
Eric Allen, SHRM-CP
Human Resources Business Partner
Company data provided by crunchbase