Senior Systems Engineer

3 weeks ago

St Louis, Missouri, United States DeepSight Technology Full time
About DeepSight Technology

DeepSight Technology Inc. is a pioneering company that has developed groundbreaking technology in ultrasound imaging. Our innovative solutions aim to revolutionize the industry by extending the range and clarity of ultrasound systems by 10x - 100x.

Job Description

We are seeking a highly skilled Senior Systems Engineer to join our team. As a key member of our engineering team, you will be responsible for developing detailed hardware requirements for our systems and ensuring alignment between user needs, product requirements, and design outputs.

Key Responsibilities:

  • Collaborate with the Product Management and Clinical Engineering team to define product requirements.
  • 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

To be successful in this role, you will need:

  • 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 either the St. Louis, MO or Santa Clara, CA areas.
  • Willing to travel up to 10%.
Preferred Qualifications

We are also looking for candidates with:

  • 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

We offer a competitive salary, stock options, medical, dental, and vision insurance, and a 401(k) retirement plan. If you are a motivated and detail-oriented individual who is passionate about medical devices, we encourage you to apply.

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