Staff Systems Engineer (CT Imaging)

Description

The company makes AI-driven, non-invasive tools for diagnosing and managing coronary artery disease, the leading cause of death worldwide. Its main product is the company FFR CT Analysis, which produces a color-coded 3D model of a patient's coronary arteries showing how blockages affect blood flow to the heart. The company's suite also covers identifying stenoses (RoadMapAnalysis) and characterizing and quantifying atherosclerosis (Plaque Analysis) across the CCTA pathway. It is publicly traded (HTFL), is cleared for use in the US, UK, Europe, Japan and Canada, and has been used for more than 750,000 patients worldwide. The product line and team are both growing.

This role is the technical lead for how the company's products perform across all CT scanners, from energy-integrating detector CT (EID-CT) to photon-counting CT (PCCT). You will report to the Sr. Director of Systems Engineering and own system requirements and the verification and validation (V&V) strategy, so that results stay accurate and consistent regardless of which scanner, detector, reconstruction kernel or technique produced the scan.

Responsibilities

• Own the strategy and system architecture that keeps product outputs consistent across EID-CT and PCCT, including scanners, detectors, reconstruction kernels and imaging techniques. Work with Engineering to close the gaps these differences create.
• Set the optimal and acceptable ranges for CT scanner and reconstruction settings that produce high-quality results.
• Work with cross-functional teams on new products, features and performance gains that use new CT technologies.
• Work with Clinical Research to design data studies that measure imaging performance and variance across machines, techniques and patient groups.
• Track CT manufacturers (such as Siemens and GE) and new market entrants. Assess how significant changes affect the system and manage the proprietary and technical details needed to support them.
• Represent Systems Engineering in design reviews, program planning and cross-functional decisions. Act as the CT expert for regulatory submissions and audits.
• Define and maintain system requirements, traced from user needs through verification, under design controls.
• Turn clinical and product goals into clear, testable requirements agreed with stakeholders.
• Spread Systems Engineering best practices across teams and mentor engineers as the group grows.

Requirements

• 10+ years of Systems Engineering experience with medical devices and/or regulated imaging products.
• Hands-on experience with CT acquisition and reconstruction on both EID-CT and PCCT, including image quality and how machine and technology differences affect it.
• Expertise in applied statistics, with experience designing analyses that measure imaging performance, variance and accuracy across machines, techniques and patient populations.
• Proven ownership of system requirements, traceability, and V&V that supported successful submissions such as 510(k), De Novo or PMA.
• Working knowledge of design control, quality, risk and software lifecycle rules for medical device software in the FDA, EU MDR and PMDA markets.
• Skilled in system design, interface definition, requirements writing, and configuration and change control for CT scanners and reconstruction kernels.
• Experience developing FDA-regulated SaMD.
• Strong written and verbal communication. You have written Systems Engineering documents that hold up under regulatory review.
• B.S. or M.S. in Systems Engineering, Electrical Engineering, Biomedical Engineering, Physics or a related field. A Ph.D. is preferred.
• Able to travel domestically and internationally on occasion.

Conditions

Occasional domestic and international travel is required.

Salary range: $200,000 to $250,000 base, plus bonus and equity. This is an estimate of the base pay range.

The company is an Equal Opportunity Employer and does not discriminate on any protected basis.

Benefits

• Bonus and equity eligibility.