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Senior Systems Engineer

2 months ago

San Diego, California, United States DeepSight Technology Full time
Job Summary

We are seeking a highly skilled Senior Systems Engineer - Hardware to join our team at DeepSight Technology Inc. As a key member of our engineering team, you will play a critical role in the development and improvement of our breakthrough ultrasound technology.

Key Responsibilities
  • Collaborate with our Product Management and Clinical Engineering teams to define product requirements that 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 have the ability to lead, develop, and execute test protocols and systems where appropriate.
  • Ensure products meet all relevant regulatory requirements and quality standards. Work closely with quality management and regulatory affairs to navigate the approval process.
  • Identify and mitigate technical risks associated with product development, ensuring that potential issues are addressed proactively. Lead 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, IEC).
  • Experience translating clinical workflows and business objectives into technical requirements.
  • Demonstrated capability with requirements development and management for medical devices.
  • Passionate about medical devices, with excellent communication and teamwork skills.
  • Willing to relocate to the Santa Clara, CA area.
  • Willing to travel up to 10%.
Preferred Qualifications
  • 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++.
What We Offer
  • Competitive salary.
  • Stock options.
  • Medical, dental, and vision insurance.
  • 401(k) retirement plan.