Senior Systems Engineer - Hardware

$125,000 - $200,000/Yr

Deepsight Technology - Saint Louis, MO

Full-time - Mid Level

Saint Louis, MO

About the position

DeepSight Technology Inc. is seeking a full-time Senior Systems Engineer - Hardware to join their innovative team. This role focuses on developing detailed hardware requirements for advanced ultrasound technology, which enhances range and clarity significantly. The position involves collaboration with various teams to ensure product requirements align with user needs and regulatory standards, while also addressing technical risks in product development.

Responsibilities

• Collaborate with the Product Management and Clinical Engineering team to define product requirements which meet product manager expectations.
• Develop and maintain system requirements, ensuring alignment between user needs, product requirements, and design outputs.
• Lead engineering teams through Hazard Analyses, Risk Assessments, and DFMEAs.
• Collaborate with cross-functional teams to identify proper traceability of requirements through verification and lead, develop, and execute test protocols and systems where appropriate.
• Ensure products meet all relevant regulatory requirements and quality standards, working closely with quality management and regulatory affairs to navigate the approval process.
• Identify and mitigate technical risks associated with product development, leading cross-functional engineering teams through corrective actions when necessary.

Requirements

• BS in an engineering or a technically related field
• 5+ years industry experience in medical imaging product development
• Experience in Design Control for regulated products and knowledge of applicable regulations (e.g. ISO13485, IEC 60601-1, IEC 60601-2-37)
• Experience translating clinical workflows and business objectives into technical requirements
• Demonstrated capability with requirements development and management for medical devices
• Excellent communication and teamwork skills
• Willing to relocate to either the St. Louis, MO or Santa Clara, CA areas
• Willing to travel up to 10%

Nice-to-haves

• PhD in Electrical/Biomedical engineering
• Knowledge in Ultrasound imaging systems
• Experience and completion of FDA submissions
• Experience in ultrasound data acquisition systems
• Demonstrated capability writing control code and test scripts with Python or C/C++

Benefits

• Competitive salary
• Stock options
• Medical, dental, and vision insurance
• 401(k) retirement plan