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We are seeking a proactive and detail-oriented AI Regulatory Engineer to ensure that AI-based clinical features for ultrasound systems comply with evolving global regulatory requirements-particularly FDA regulations for AI-enabled medical devices.
This role is critical as AI has become a highly regulated domain, requiring specialized regulatory strategies, risk management approaches, and lifecycle governance. The AI Regulatory Engineer will work closely with AI engineering, clinical, quality, product management, and regulatory affairs teams to define and execute the correct AI regulatory and submission strategy across the full product lifecycle.
Job Description
Key Responsibilities
AI Regulatory Strategy & Compliance
Interpret and apply regulatory frameworks and guidance for AI-enabled medical devices, including FDA, EU MDR/IVDR, and global regulations.
Define and drive AI regulatory strategies for clinical ultrasound features, including SaMD and AI-enabled device functions.
Support FDA submission pathways (e.g., 510(k), De Novo, PMA) for AI-based features, including AI-specific regulatory positioning.
Risk Management & Safety for AI
Lead AI-focused risk management activities in accordance with ISO 14971, addressing AI-specific hazards such as bias, robustness, generalization risk, and clinical misuse.
Perform and maintain AI-specific risk analyses (e.g., AI FMEA, algorithm hazard analysis, clinical performance risk).
Ensure traceability between clinical requirements, AI behavior, risk controls, and verification/validation evidence.
Regulatory Documentation & Submissions
Prepare and maintain AI-related regulatory documentation, including:
AI descriptions and intended use statements
Training and validation dataset descriptions
Performance evaluation and clinical evidence summaries
Algorithm change management and lifecycle documentation
Support creation of FDA-ready AI documentation, including transparency, explainability, and human-factors considerations.
AI Lifecycle & Change Management
Define regulatory-compliant processes for AI updates, retraining, and post-market changes, aligned with FDA expectations.
Support implementation of Predetermined Change Control Plans (PCCP) or equivalent AI lifecycle strategies.
Ensure alignment between AI development practices and regulatory expectations for locked vs. adaptive algorithms.
Cross-Functional Collaboration
Collaborate closely with:
AI engineers and data scientists
Clinical and medical affairs teams
Quality, systems, and V&V engineers
Product management and regulatory affairs
Embed regulatory and safety requirements early into AI design, data strategy, and clinical validation plans.
Regulatory Intelligence & Audits
Monitor evolving AI regulations, FDA guidance, standards, and industry best practices.
Communicate regulatory changes and their impact on AI roadmaps and product strategy.
Support internal audits, design reviews, and external regulatory inspections related to AI and clinical safety.
Provide training and guidance on AI regulatory and safety topics to engineering and product teams.

Systems engineering is a cross-functional engineering discipline centered on an approach, mindset, and process. All activities that consider both the business and the technical needs of the customers with the goal of providing a quality product that meets the users needs. The discipline that executes a robust process of design, creation, and optimization of systems, consisting of identification and quantification of system requirements, creation of alternate system design concepts, performance of design trade studies, selection and implementation of the best designs and verification that the design is properly integrated and executed. Process that proceeds from concept to production to operation.
Responsible for departmental operations planning/execution or is focused on execution of professional activities within a technical discipline. Functions with some autonomy but guided by established policies or review of end results.
The job allows modification of procedures and practices covering work as long as the end results meet standards of acceptability (quality, volume, timeliness etc.).
Job Description
Roles and Responsibilities
Conducts component and product integration. All activities that span multiple components and products and are concerned with how to integrate for maximum performance and operability. Manages product and systems requirements, specifications and flow down. Drives validation and verification activities for the overall product/system, including system level testing. Responsible for defining product requirements for the module / component / subcontractors and partners teams. Manages interface between components and execution organizations.
Responsible for driving CTQ / Risk trades within the teams designing the components. Manages the overall product configuration and configuration control system.
Includes direct people management responsibility including staffing and performance development. Utilizes in-depth knowledge of a technical discipline and analytical thinking and technical experience to execute policy/strategy.
Has knowledge of best practices and how own area integrates with others; is aware of the competition and the factors that differentiate them in the market
Uses some judgment and has some ability to propose different solutions outside of set parameters to address more complicated manufacturing processes with technical variety and/or interdependent production cycles. Uses technical experience and analytical thinking. Uses multiple internal and limited external sources outside of own teams to arrive at decisions.
Acts as a resource for colleagues with less experience. May lead small projects with low risks and resource requirements. Explains information; developing skills to bring team members to consensus around topics within field. Conveys performance expectations and may handle sensitive issues.

The Lead Clinical Applications Engineer is a role within R&D, focused primarily on new product introduction and continuous improvement of post-market Nuclear Medicine and/or PET-CT imaging systems and related software. The role provides clinical and application expertise to product and engineering teams, ensuring solutions meet clinical needs, deliver strong image quality and quantification, and perform reliably in real‑world use.
Working closely with R&D, system engineering, product management, service, and field teams and customers, this role translates clinical needs, customer feedback, and usage insights into practical system and software improvements, while supporting resolution of complex clinical and application‑related issues.
Job Description
Lead Clinical Applications Engineer
Key Responsibilities
Serve as a clinical reference for Nuclear Medicine and PET-CT applications and workflows within R&D programs.
Support investigation of selected complex customer or field issues, translating findings into actionable inputs for product improvement.
Interface with product, software, algorithms, system engineering, hardware, UX, service, and field organizations as needed.
Translate clinical use cases and user needs into system and software requirements in collaboration with engineering teams.
Support design and validation of Nuclear Medicine and PET-CT applications, reconstruction methods, and workflow solutions.
Provide clinical input to decisions impacting image quality, quantification accuracy, dose, and user experience.
Participate in evaluation of AI‑enabled Nuclear Medicine and PET-CT, supporting clinical validation and performance claims.
Contribute to usability, clinical validation, and regulatory‑related documentation as required.

As part of our companys Point of Care Ultrasound business, this role focuses on activities that contribute to the design and development of innovative ultrasound products and their interaction with the human body. You will play a key part in planning and executing tasks that impact departmental operations, ensuring compliance with standard functional practices and procedures. While the position offers some autonomy, it is primarily centered on delivering high-quality execution within an established operating discipline. Some judgment may be required, offering guidance to other team members.
Join us in transforming patient care by bringing advanced imaging closer to clinicians- helping them make faster, more accurate decisions when it matters most.
Job Description
Roles and Responsibilities
Technical Product Leader
Design and define clinical applications- AI tools, clinical and workflows applications, according to user needs communicated by product managers, clinical team, field feedback and physicians.
Project management collaborating with multifunctional teams: software, algorithms, system, program, mechanics, UX\UI designer, verification, clinical team and product managers.
Documentation of product requirements- design input and output.
Review verification plans and procedures.
External evaluation sites support.
Regulatory submission support.

we are seeking a Lead Systems Engineer with a strong background in electronics and a solid understanding of electronic systems to drive Point-of-Care Ultrasound systems engineering activities across the full product lifecycle.
Job Description
Key Responsibilities:
Lead and manage system-level requirements and specifications throughout product development
Drive system verification and validation activities, including end-to-end system testing
Act as the primary interface between Algorithm, Software, and Verification & Validation (V&V) teams
Lead product risk management activities in accordance with regulatory and quality standards
Drive resolution of complex technical issues to ensure project milestones and goals are met
Collaborate closely with Program Management to support scheduling, mitigate technical risks, and inform decision-making through sound engineering judgment.

We are seeking an experienced and self-driven Senior Mechanical Engineer to join our Ultrasound Point of Care (POC) R&D team. In this role, you will be responsible for leading the mechanical design, development, verification, and transition to manufacturing (NPI) of compact ultrasound systems, consoles, and system accessories.
This position emphasizes complete end-to-end mechanical ownership-from initial conceptual design, detailed CAD modeling, and DFM to collaborating with external subcontractors, managing tooling approvals, and ensuring seamless integration on the manufacturing line.
Job Description
Key Responsibilities
Mechanical Design & Engineering: Drive the mechanical design and electronics packaging of compact ultrasound hardware, consoles, suspended masses, sheet metal structures, and custom system accessories from initial concept through mass production.
Subcontractor & Vendor Collaboration: Collaborate with external subcontractors, injection molding suppliers, tooling vendors, and design agencies (including overseas suppliers in China and globally) to ensure design feasibility and quality.
DFM & Production Readiness: Oversee Design for Manufacturability (DFM) reviews, tool design approvals, sample inspections, and root-cause analysis for plastic injection parts, metal forming, castings, and extrusions.
Design Control & Documentation: Author and maintain technical documentation, including System/Mechanical Requirements Specifications (DRS), Verification Protocols (VPR, VRS), Engineering Change Requests/Orders (ECR/ECO), assembly drawings, and Bill of Materials (BOM).
Compliance & Standards: Ensure mechanical design compliance with medical device standards, cleaning & disinfection guidelines (ISO 17664), system labeling, and environmental/regulatory requirements.
Testing & Assembly Line Support: Design test fixtures, write verification plans, execute mechanical testing, and provide real-time engineering support to assembly floors and production lines.

The Algorithm Software Engineer will contribute to the design, implementation, testing, and performance optimization of tomographic image reconstruction software for our company Molecular Imaging scanners.
This is an exciting opportunity for an outstanding early-career engineer to work at the intersection of software, algorithms, high-performance computing, and medical imaging. We are looking for exceptional graduates with strong technical foundations, intellectual curiosity, and the ability to solve complex problems.
No prior professional experience is required. Academic, research, personal, or internship projects demonstrating strong technical capabilities are highly valued.
Job Description
Roles and Responsibilities
Develop and implement reconstruction algorithms and software tools in C++ within parallel CPU/GPU environments.
Collaborate with algorithm engineers and scientists to understand mathematical and physical algorithms and translate them into robust software solutions.
Contribute to the architecture and design of complex software components.
Collaborate with software teams to define interfaces between the reconstruction environment and other software subsystems.
Analyze and optimize software performance, runtime, and memory usage.
Write software requirements, design documents, and technical specifications.
Design and execute software unit tests.
Support the Verification & Validation team in defining and executing system testing plans.
Support technical investigations and field-related issues as needed.
Participate in code reviews and technical reviews.
Maintain configuration management and control of generated code.
Continuously learn and apply new technologies in software engineering, algorithms, and high-performance computing.

The Reconstruction Software Engineer is responsible for design and implementation of medical imaging tomographic reconstruction software, through definition of architecture, design, coding and performance optimization. The software is part of our company Molecular Imaging scanner products.
Job Description
Roles and Responsibilities
Coding of algorithms and reconstruction tools in C++ / OpenCL / CUDA parallel environments.
Architecture and design of complex software subsystems.
Work with algorithms engineers and scientists to understand mathematical and physical algorithms, and design optimal solutions to implement the algorithms.
Work with other software teams to define interfaces between the Reconstruction environment and other software subsystems.
Optimize reconstruction engines to meet performance run-time requirements and usage of memory resources.
Write software requirements and design documents.
Design and execute software unit-tests.
Define and support Verification & Validation team in design and execution of system testing plans.
Support field investigations - upon need.
Data and configuration management and control of generated code.
Initiate and conduct technical reviews of work done.
Get to know trends and new technologies in the computing and software industry.

The clinical application engineer serves as the core clinical knowledge of the product development and/field support phase for SPECT/CT, PET/CT and radiology reading solutions. Your main responsibilities include:
Gathering, prioritizing, and shaping user requirements.
Designing new applications and features.
Close collaboration with cross-functional engineering groups to feed customer needs into detailed engineering design requirements
Supporting product life cycle activity such as usability, user manuals, application training, regulatory submissions, clinical evaluation summary report, medical evaluations, and product pilots.
Work in close collaboration with customers, internal/external stakeholders. Supporting the field with advanced customer queries.

we are a leading manufacturer of medical imaging devices. our companys Point of Care Ultrasound Algorithm team is looking for an experienced AI Algorithm Developer to take ownership of challenging imaging and guidance problems.
You will develop algorithms that connect physical imaging processes, clinical needs, and product behavior. The role combines hands-on algorithm development with independent technical judgment, close collaboration across disciplines, and responsibility for delivering reliable results.
We are looking for someone who wants to understand why a solution works, recognize where it fails, and take responsibility for improving it.
Job Description
Responsibilities
Independently own algorithm workstreams, from understanding the problem and defining the technical approach through implementation, evaluation, and integration.
Translate clinical and product needs into clear algorithm requirements, measurable success criteria, and practical development plans.
Develop solutions combining deep learning, computer vision, image processing, and mathematical modeling, selecting methods appropriate to the problem.
Understand how imaging physics, acquisition geometry, artifacts, and system constraints affect the data and algorithm behavior.
Define data and annotation requirements, design reproducible experiments, investigate failure cases, and use findings to guide improvements.
Work with software, imaging, clinical, and product teams to resolve dependencies and balance accuracy, robustness, latency, and computational requirements.
Use generative AI tools thoughtfully to accelerate research, coding, testing, and analysis, while verifying outputs and retaining responsibility for technical decisions and results.
Deliver maintainable code and clear technical documentation supporting integration, verification, and regulatory activities.

As a Software Engineer - PET Data Acquisition, you will join a highly specialized team developing the real-time software stack at the core of our companys PET/CT imaging systems.
Our software directly impacts image quality and system reliability, enabling clinicians worldwide to provide accurate diagnoses and life-saving care.
You will work on a distributed, high-performance C++ system running on Linux, responsible for configuring detector hardware, processing high-throughput data streams, and enabling seamless integration across the scanner ecosystem.
Job Description
About the Team
Our team develops the data acquisition platform powering our companys PET/CT scanners.
This system:
Configures and interfaces with detector hardware
Receives high-rate event streams via UDP
Performs real-time sorting and time-stamping of coincidence events
Manages acquisition state and persistence
Exposes control and monitoring APIs to clinical applications
The platform is a distributed, multi-process, multi-threaded C++ system running on Linux, designed for deterministic, high-performance operation under demanding workloads.
Key Responsibilities
Design and develop end-to-end data acquisition features, from low-level UDP capture and event processing through service layers and client APIs
Optimize and maintain performance-critical code paths, including:
Lock-free / low-contention data structures
Thread affinity and NUMA optimization
Zero-copy buffer management
Deterministic real-time execution
Enhance and maintain inter-process communication mechanisms, including shared memory, message queues, and service interfaces
Work with embedded persistence layers (SQL-based) for configuration, metadata, and runtime state
Collaborate closely with hardware, physics, and system teams to integrate new detector and system components
Develop unit and integration tests, and actively participate in code and design reviews
Troubleshoot complex cross-process issues using advanced debugging and profiling tools (e.g., gdb, perf, tcpdump, strace).

The Lead Clinical Applications Engineer is a role within R&D, focused primarily on new product introduction and continuous improvement of post-market Nuclear Medicine and/or PET-CT imaging systems and related software. The role provides clinical and application expertise to product and engineering teams, ensuring solutions meet clinical needs, deliver strong image quality and quantification, and perform reliably in real‑world use.
Working closely with R&D, system engineering, product management, service, and field teams and customers, this role translates clinical needs, customer feedback, and usage insights into practical system and software improvements, while supporting resolution of complex clinical and application‑related issues.
Job Description
Lead Clinical Applications Engineer
Key Responsibilities
Serve as a clinical reference for Nuclear Medicine and PET-CT applications and workflows within R&D programs.
Support investigation of selected complex customer or field issues, translating findings into actionable inputs for product improvement.
Interface with product, software, algorithms, system engineering, hardware, UX, service, and field organizations as needed.
Translate clinical use cases and user needs into system and software requirements in collaboration with engineering teams.
Support design and validation of Nuclear Medicine and PET-CT applications, reconstruction methods, and workflow solutions.
Provide clinical input to decisions impacting image quality, quantification accuracy, dose, and user experience.
Participate in evaluation of AI‑enabled Nuclear Medicine and PET-CT, supporting clinical validation and performance claims.
Contribute to usability, clinical validation, and regulatory‑related documentation as required.

This position refers to leading the design of parts and assemblies for the company imaging systems (PET, SPECT). The position includes working inside an NPI project or supporting the systems in the field (Install Base). The mechanical design of parts and assemblies includes working with multi-disciplinary teams including electronics, system engineering, service engineering and involves transfer of designs to production, support of high-level-assembly lines, etc. This position involves the writing of safety files, planning and execution of V&V tests, engineering calculations and FEA simulations, writing specifications and failure analysis.
Job Description
Essential responsibilities:
Mechanical design derived from specifications (as well as writing specifications), as part of a multi-disciplinary team of parts and assemblies while using off-the-shelf components, using 3D CREO CAD design package. Presenting the design in technical design reviews at the levels of concept and detail design is a part of this position,
Developing creative design solutions in response to the product requirements of functionality, reliability, cost, manufacturability, etc.,
Support of company products at hospital and customer sites via the Service Teams as needed,
Building safety files for products, including strength calculations, failure modes analysis (FMEA), compliance with safety and medical industrial standards as well as internal company standards,
Supporting transfer to production, defining basic assembly and service instructions, working with parts suppliers,
Defining verification and validation test procedure, tests execution and report writing.
Essential qualifications /requirements:
Mandatory: 1st degree in mechanical engineering
Mandatory: Good personal, teamwork and communication skills, enthusiasm from study, self-motivated, results oriented,
Work experience of 2 years in mechanical design, with experience in at least 2 of the following: design of motion systems, large welded or cast structures and frames, mechanisms, electronic packaging, large sculptured FRP covers, electrical design support (DXF, cables routing),
Experience in machining and sheet metal technologies,
Experience in prototype building (hands on), testing execution per test plan and failures troubleshooting
Fluent English at presentation level in technical design reviews, Zoom/Teams calls and in writing.
Desired Characteristics by priority:
Leading tasks from requirements to engineering change finalization,
System level understanding in multi-disciplinary project environment,
Definition of testing and report writing,
Experience in design for cost, reliability, serviceability and for manufacturability.
Ability to perform finite-element analysis and Excel level technical calculations,
we are a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.