Senior Systems Engineer, Software Focus - DeepSight Technology

Senior Systems Engineer, Software Focus

Job Description

We are looking for an engineer with a strong background in medical device requirements development, system decomposition, risk analysis, VoC (Voice of Customer) translation, system architecture and behavior definition, and Verification & Validation (V&V) support. As a Senior Systems Engineer, you will bridge the gap between technical teams and business stakeholders, ensuring that our products meet the highest standards of quality and compliance. The primary focus of this role is to develop detailed requirements for subcomponents from input for product management, user interface design, and clinical engineering.

As a Senior Systems Software Engineer, your responsibilities are:

• Collaborate with the Product Management and Clinical Engineering team to define product requirements which meet product manager expectations.
• Act as a liaison between technical teams and business stakeholders, effectively communicating product requirements and updates.
• Develop and maintain system requirements and specifications, ensuring alignment between user needs, product requirements, and technical specifications.
• Collaborate with cross-functional teams including engineering, design, regulatory affairs, quality assurance, and manufacturing to ensure seamless execution of projects.
• Work collaboratively to develop high level algorithms, architectures and/or approaches to bridge clinical needs and implementation
• Ensure products meet all relevant regulatory requirements and quality standards. Work closely with regulatory affairs to navigate the approval process.
• Identify and mitigate technical risks associated with product development, ensuring that potential issues are addressed proactively.
• Develop verification test protocols to verify system functionality

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 and IEC 62304)
• Experience translating clinical workflows and business objectives into technical requirements
• Demonstrated capability with requirements development and management for medical devices
• Experience writing and executing test protocols
• Passionate about medical devices, with excellent communication and teamwork skills

Preferred Qualifications:

• MS or PhD in Electrical/Biomedical engineeringx
• Knowledge in medical imaging (Ultrasound, PET, SPECT, CT, MR, etc.)
• Experience working in an Agile Development process

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 of $120,000 to $180,000
• Stock options
• Medical, dental, and vision insurance
• 401(k) retirement plan