Systems Engineer

KARL STORZ•Charlton, MA

15h

About The Position

We are seeking an experienced Systems Engineer to lead the design and development of complex products at the system level. The successful candidate will collaborate closely with cross-functional teams, including product management, project management, development, and production, to ensure products meet customer, manufacturing, service, market, and regulatory requirements.

Requirements

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

Nice To Haves

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

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