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We are seeking 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 this role is to develop detailed hardware requirements for systems down to the subcomponent level and to be directly involved in ensuring traceability through Verification and Validation.

Key Responsibilities:

• Collaborate with Product Management and Clinical Engineering teams to define product requirements that align with product manager expectations.

• Develop and maintain system requirements, ensuring they meet user needs, product requirements, and design outputs.

• Lead engineering teams in conducting Hazard Analyses, Risk Assessments, and DFMEAs.

• Work with cross-functional teams to ensure proper traceability of requirements through verification and lead the development and execution of test protocols and systems as needed.

• 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, proactively addressing potential issues. Lead cross-functional engineering teams through corrective actions when necessary.

Required Qualifications:

• BS in engineering or a related technical field.

• 5+ years of 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.

• Proven capability in requirements development and management for medical devices.

• Passion for medical devices, with strong communication and teamwork skills.

Preferred Qualifications:

• PhD in Electrical/Biomedical Engineering.

• Knowledge of ultrasound imaging systems.

• Experience in completing FDA submissions.

• Experience with ultrasound data acquisition systems.

• Proficiency in writing control code and test scripts with Python or C/C++.