דרושים » הנדסה » Quality Engineer for a Medical Device Company

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.

We are looking for a Clinical Manager to join our Aesthetics Business Unit, which includes a broad portfolio of leading market solutions as well as an exciting innovation pipeline.
The Clinical Manager will be responsible for pre-market and post-market clinical activities for the assigned platform, including defining clinical requirements to guide design input, leading pre-clinical validation planning and execution, providing clinical input to regulatory submissions, supporting market conditioning for new solutions, generating post-market clinical evidence, and developing relationships with key opinion leaders.
This role is a key pillar in demonstrating the clinical value, safety, performance, and benefits of solutions, while strengthening relationships with global KOLs, clinical investigators, and cross-functional stakeholders.
Key responsibilities:
Develop and manage end-to-end clinical project plans, timelines, and budgets, from early clinical research and pre-clinical validation through clinical trials, publications, user guidelines, and post-market evidence generation.
Drive cross-functional collaboration across multiple interfaces and business units.
Conduct deep clinical and scientific assessments, including review of the standard of care, clinical trends, mechanism of action, and emerging technologies, to support current and future product development and innovation.
Define pre-clinical validation strategies and lead pre-clinical evaluation activities
Lead the strategy, planning, and execution of clinical studies, ensuring adherence to study protocols, ethical requirements, Good Clinical Practice, regulatory requirements, timelines, and budgets.
Form and cultivate strong collaborative relationships with cross-functional partners in R&D, product management, marketing, regulatory affairs, quality assurance, clinical training, and regional commercial teams.
Lead clinical input and support for key regulatory submissions and processes, including clinical rationales, clinical validations, clinical evaluation reports, and clinical development plans.
Support marketing and commercial activities from a scientific and medical perspective, including review and input into marketing collateral, development of white papers, clinical summaries, presentations, training materials, and active participation in scientific meetings.
Communicate project status to stakeholders, providing clear updates on milestones, deliverables, risks, mitigation plans, and key decisions.

Rapid Medical is a fast-growing medical device company focused on developing, manufacturing, and selling innovative devices for endovascular interventional procedures. We are looking for a talented and creative engineer to join our R&D team and be a key player in our future development. LOCATION: Yokneam, Israel
SCOPE & RESPONSIBILITIES:
* Design and develop innovative neurointerventional medical devices as part of the R&D team.
* Plan and execute verification tests for new prototypes and new products
* Prepare product documentation, including DHF and DMR
* Analyze test results and author detailed engineering reports
* Collaborate with Quality and Regulatory Affairs to ensure design control compliance
* Lead design transfer activities, support pilot production, and transition products into manufacturing

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.

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.

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.

The Warehouse/Production Quality Inspection Leader performs incoming and outgoing product inspection of finished products and assemblies for good manufacturing practices (GMP) to verify product meets specifications and are free of damage or defects.
This role is responsible for Material Identification & Segregation, documentation configuration control practices; performing incoming and outgoing product inspection of finished products, finished medical devices and assemblies for good manufacturing practices (GMP) to verify product meets specifications and are free of damage or defects.
This role will require autonomy to make decisions within a defined framework: Resolves issues in situations that require good technical knowledge and judgment within established procedures. Consults more senior team members for issues outside of defined instructions/parameters. Lead a team of Quality Inspectors through professional guidance and technical expertise.
Documentation & disposition of non-conforming material, and Good Documentation Practices requirements, as associated with this job type/position Aware of and comply with the company HC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position.
Job Description
Essential Responsibilities
Conduct visual and measurement tests, read Specifications to understand the requirements of products Inspect, test, or measure materials, products, installations - verify comply with specifications to mark material as acceptance or rejection status Discuss inspection results with those responsible for products, and recommend necessary actions Select output samples and check them using predefined appropriate methods Communicate and escalate with production team leader quality control concerns to improve product excellence Work with cross-functional teams and assists with implementation of process improvements to increase quality and productivity.

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.

Required QMS Quality Engineer
About the team:
The Quality team verifies that automotive standards & best practices such as ASPICE, IATF 16949, VDA 6.3, and ISO 9001 are implemented, and it continuously works to ensure qualified work products & processes across the entire organization.
The MEQ team works with internal stakeholders/departments & external parties (customers, suppliers) to achieve the best quality products & services.
What will your job look like:
Drive quality across the entire organization - define cross-company processes with relevant stakeholders and monitor their effectiveness via agreed KPIs.
Perform internal assessments and support external assessments.
Define templates and perform training/coaching (processes, best practices, implementation of processes via correct use of tools, etc.)
Work with management - set a quality work plan and measurable goals and present their achievement, based on factual data, during Quality Management Reviews (QMRs).
Drive continuous improvement via lessons learned & factual collected data.
Support quality-related issues with customers and suppliers.

The Staff Machine Learning Engineer is a senior technical leader responsible for designing, developing, and deploying production-grade AI systems for our company medical imaging products. This role focuses on vision-language models, diffusion models, and multimodal learning, working closely with data scientists, software engineers, product leaders, and clinical experts to turn advanced AI methods into robust product capabilities.
Key Responsibilities
Design, implement, and productionize AI models for clinical applications, including vision and diffusion models.
Own end-to-end model lifecycle: data ingestion, training, evaluation, deployment, monitoring, and iteration.
Work with large-scale medical datasets, ensuring data quality, preprocessing, and efficient pipeline management.
Drive technical decisions and tradeoffs with a focus on scalability, maintainability, and real-world constraints.
Collaborate with clinical AI scientists to translate research innovations into production-ready solutions.
Stay current with advancements in vision-language modeling, GenAI, and related AI technologies.