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we are looking for a QA Engineer.
Job Requirements & Responsibilities
Support and manage core quality activities, including Non-Conformance Reports (NCR), Corrective and Preventive Actions (CAPA), Complaints, and Change Control (ECO).
Assist in the performance and preparation of both internal and external quality audits.
Coordinate and follow up on employee training, qualification, and competency activities to ensure organizational compliance.
Support the qualification and ongoing evaluation of suppliers.
Support the production activities (Review Device History Records (DHRs) and quality documentation for completeness and batch release).
Participation in Design Reviews and verification of execution of Action Items related to quality issues.
Provide quality support for V&V processes, including software validation, equipment validation, and the review of engineering documents.
Administer controlled documents and maintain quality records.

we are a well-funded medical startup transforming ICU care through advanced technology and innovation. Our smART+ platform is an intelligent, sensor-based solution that optimizes nutrition delivery while reducing the risks of ventilator-associated pneumonia and malnutrition. Supported by clinical trials, we are setting a new standard in critical care by achieving nearly 100% feeding efficiency and reducing ICU stays by an average of 3.3 days. We are seeking an experienced and driven Usability Manager to lead the Human Factors domain throughout the entire product lifecycle. This role operates in a dynamic startup environment and requires close alignment with stringent regulatory standards (FDA / EU MDR). Responsibilities:
* Lead the strategy, planning, and execution of User Experience, User Interface, and industrial design activities, including defining milestones, objectives, and deliverables in compliance with regulatory requirements (FDA, EU MDR).
* Establish and implement structured Human Factors and usability processes, ensuring proper documentation and traceability to support regulatory submissions.
* Collaborate closely with cross-functional teams including R&D, engineering, clinical, regulatory affairs, and Quality Assurance to ensure optimal User Experience aligned with product and system requirements.
* Plan and conduct user research activities to understand user needs, workflows, environments of use, and clinical use scenarios; synthesize insights into actionable design recommendations.
* Design, manage, and execute formative and summative usability studies, including protocol development, data analysis, reporting, and driving design improvements based on findings.
* Provide Human Factors expertise across the entire product lifecycle, including use-related risk analysis, contribution to the Design History File (DHF), and regulatory documentation.

we are seeking an Engineering Manager to lead the transition of its medical devices from R&D into scalable, compliant, and cost-effective production. This role owns the Design Transfer process, drives validation and qualification efforts, maintains the engineering and manufacturing BOMs, and provides hands-on support to production. The Engineering Manager will collaborate closely with Operations, Quality, and R&D to ensure manufacturability, robustness, and readiness for global scale.
The ideal candidate has deep hands-on engineering experience in medical devices, strong knowledge of manufacturing processes, and thrives in fast-paced, cross-functional environments.

We are seeking a talented and motivated Affera and Single Shot Therapy Account Consultant to join our team to further drive the growth of the business.
Reporting to the operating unit this role is critical in providing expert clinical and technical support and training to physicians and Electrophysiology Lab Staff on the optimal use of the Affera Mapping and Ablation System and the use of our single shot technologies (Cryo and PulseSelect).
Responsibilities may include the following and other duties may be assigned:
Provide proficient clinical and technical assistance to physicians and EP Lab Staff on the use of the Affera Mapping and Ablation System and related equipment (Generators, SW functionalities, pump and accessories). Both Single shot technologies - Cryo and PulseSelect.
Provide in-service training to introduce new technologies to various hospital stakeholders and ensure technology acceptance.
Play an active role in the planning and effective installation of the Affera Mapping and Ablation System and efficiently collaborate with the technical department.
Share clinical best practices with colleagues to continuously optimize customer experience.
Work with field service engineers on technical troubleshooting.
Support sales processes in dedicated accounts .
Participate in regional and occasionally international congresses, symposia and workshops.

In this position, you will develop and execute regulatory strategy, work closely with R&D and Engineering departments to provide regulatory inputs relevant to product development and changes, write and submit submission packages to FDA, EU, and work closely with worldwide RA partners
Key Responsibilities:
Actively contribute in the development of regulatory strategies for software and product development and approval, as well as product lifecycle maintenance. You will be able to support regulatory activities and global strategy for product launch.
Define and prepare document packages for US FDA regulatory submissions, EU MDR Technical Files, and international packages.
Assess product changes and their global regulatory impact.
Ensure timely license renewal and annual registrations for internal and external partners
Interact with internal marketing, R&D, QA, project managers as well as external Regulatory partners.
Recommend changes for labeling, design, manufacturing, marketing, and clinical protocols for regulatory compliance.
Perform and document regulatory assessments of life-cycle changes according to regulatory requirements of the U.S. FDA, E.U., and rest of world (ROW)
Identify and communicate regulatory risks and mitigations
Monitor and document post marketing activities, analysis of trends, vigilance processes.
Respond to Information requests from regulatory Authorities
Explore submission pathways and regulatory opportunities, and recommend the most appropriate route according to regulation and business needs and priorities
Utilize strategic regulatory thinking along with technical expertise to implement regulatory strategies for post-approval changes