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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

we are seeking a Senior Design Quality Assurance Engineer for our Urology division. This role involves developing, supporting, and managing risk for Medical Electrical Equipment/Systems (MEE/MES) and related accessories as part of New Product Development. Become part of a team shaping the future of the operating room, with a focus on advanced kidney stone treatments and innovative solutions for physicians and patients. Lead the development of safe, high-quality products and make a direct impact on patient care and clinical outcomes.

Your responsibilities include:

Lead product teams within the BSC Quality System to develop new MEE and MES as part of a core group of DQA Engineers supporting the Laser Therapies franchise. Special focus on:
Engagement with project teams for Systems Engineering and Systems Risk Management as a Subject Matter Expert (SME).
Utilize Systems Engineering practices to lead efforts for requirements management/system architecture to align risk mitigations with design inputs, design outputs at different levels (e.g., system / sub-system) for products that are both stand alone, and network connected.
Lead NPD projects as a DQA SME and work with R&D Product Development Engineers to review Hardware/Software systems architecture(s) and identify possible failure modes/risk control opportunities for these complex systems.
Lead Risk Management activities during all phases of Electrical HW/SW design, using design quality assurance principles applicable to FDA/EUMDR-Regulated Class II Medical Device environments (including interconnected software systems).
Participate and lead in the creation and maintenance of Risk Management and Usability deliverables.
Lead and/or support development of NPD Reliability Engineering Program Plans and related reliability program activities.
May perform other duties as directed.

we are looking for a Software Quality Engineer.
Main Responsibilities:
Manage, planning and execution of components level and E2E system tests with documented test results.
Participate in the verification and validation testing of the current and future products.
Ownership of designing, planning, and writing verification and validation testing documentation for existing and future products/features/modules, according to requirements.
Provide effort and time estimations of testing process for existing and future products/features/modules.
Lead the maintenance and definition of SW life-cycle related tasks including documentation and other regulation related issues.
Collaborate with Development, Applications, Project Management and Customer Support team members throughout the lifecycle of a project/product.
Assist other testing engineers with testing assignments and/or training.
Participate in customer and field issues support investigation.