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.
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 either the St. Louis, MO or Santa Clara, CA areas.
- 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++.
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.
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