Senior Systems Engineer - Hardware - DeepSight Technology

Are you an experienced systems engineer looking to advance your career in a pioneering startup? DeepSight Technology Inc. is seeking a full-time Senior Systems Engineer - Hardware to join our innovative team. Our breakthrough ultrasound technology enhances range and clarity by up to 100x, setting new industry standards. With a competitive salary range of $125,000 - $200,000 per year, this is an exceptional opportunity to contribute to cutting-edge advancements.

All About Us:

DeepSight Technology Inc. is a stealth-mode startup company that has developed breakthrough technology in ultrasound imaging. This new technology will extend both the range and clarity over current systems by 10x - 100x! We are setting new standards that will dramatically improve the capabilities of ultrasound for many years.

In order to develop and improve this technology, we need dedicated team players on our side. Not only do we offer a great team-oriented environment, but we also offer competitive compensation and generous benefits.

Job Description:

We are looking for an engineer with a strong background in medical device requirements development, system decomposition, risk analysis, system architecture and behavior definition, and Verification & Validation (V&V) support. The primary focus of the role is to develop detailed hardware requirements for the systems we build to the subcomponent level and be directly involved in the traceability through Verification and Validation.

As a Senior Systems Engineer, your responsibilities are:

• 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 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

Required Qualifications:

• 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
• 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++

Other Qualities We Are Looking For:

• Positive - a can-do attitude that helps you rise to challenges
• Collaborative - a team player who can effectively communicate with others
• Attentive to detail - nothing gets by you
• Efficient - a knack for effectively prioritizing tasks and managing your time
• Pride in your work - real desire to do quality work
• Career-minded - looking for more than a job
• Empathy - a mindset of producing quality products that help people

Benefits and Perks:

We offer great benefits and perks:

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

If you are ready to join a leading-edge team dedicated to transforming ultrasound technology as our new Senior Systems Engineer - Hardware, we encourage you to apply. Our initial application process is quick and mobile-friendly, taking only 3 minutes to complete.