לוח משרות דרושים מהנדס ביו רפואי משרה מלאה, לחיפוש זה נמצאו 26 משרות

We are seeking a Lead Systems Engineer 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.

Required Verification Engineer
Job Description Summary
Responsible for running various verification activities on PET medical products that covers multi-disciplinary aspects from SW/HW, electronics, mechanics, physics, image quality and radiation - which is safety for users and monitored by a tag all the time.
Job Description
Job Description:
Responsible for planning and implementing verification methodologies and ensuring proper fulfillment of system and sub-system requirements.
Responsible for reviewing various product designs, verifying its functionality in agile testing methods.
Responsible to determine the testing environments and tools.
Analyze and debug system failures and issue found during testing, while delivering detailed reports identifying these issues for further investigation.
Work closely with development teams
Non-hybrid, full-time position on site
Flexible on working hour, including 2-3 evening shifts (14:00-23:00) per week as needed
Working on global programs that required tight collaboration with global and Israel teams.

We are looking for a Technical Project Engineer for the Engineering team. The Technical Project Enginee will be responsible for leading Engineering projects for cost-reduction & sustain engineering
If you want to work in an innovative, international environment and help push the boundaries of healthcare, well-being, and energy-based technology, this is your opportunity!
Main Duties:
Leading Advanced Engineering Projects for Medical multidiscipline system, focusing on value engineering and BOM (Bill of Material) cost-reduction efforts.
Leading E2E (End-2-End) Projects ECO's, from PoC/E (Proof of Concept/Experiment) thought design & Testing (V&V), up to NPI and Production implementation.
Write and Execute Design Verification Testing (V&V) for cost-saving & Sustain engineering projects.
Updating/Creating the BOM & DMR of the System within project in the PLM system.
Write and Execute Manufacturing Validation Testing (PV/MP) from planning through execution & implementation in production sites.
Quality Gate Keeper ensuring overall device safety, efficacy and compliance are withstanding the overall system quality level.

Rapid Medical is a fast-growing medical device company focused on developing, manufacturing, and selling innovative devices for endovascular interventional procedures. We are seeking a talented QA/RA Engineer to join our quality and regulatory team, playing a dual role that ensures our products meet the highest quality standards while navigating complex global regulatory requirements.
SCOPE & RESPONSIBILITIES Quality Assurance • Manage ECOs: conduct risk assessments, update relevant DMR documents and carry out necessary IQ, OQ, PQ activities if required, finalization of implementation tasks. • Manage DCOs in the PLM system: write and update QA procedures to ensure compliance with quality standards and regulatory requirements. • Manage NCR and CAPA processes: lead, write and supervise the NCR and CAPA processes, ensuring timely and effective resolutions. • Manage QA production activities: provide quality support to production operations, addressing deviations and non-conformities to maintain high product quality. • Ensure timely resolution of quality issues: promptly address all identified or assigned quality issues to prevent delays and maintain efficient operations. • Participate in internal and external audits, such as FDA inspections and notified body audits based on ISO 13485, EU MDR, and MDSAP requirements. • Supplier Quality Management: manage supplier qualification and performance monitoring, including SCAR management, and support supplier audits.
Regulatory Affairs • Prepare, coordinate, track, and follow up on submissions for medical devices across various international markets. • Prepare and manage EU MDR technical documentation submissions. • Oversee CER, PMS, and PMCF activities, including customer complaints, vigilance, and recall. • Participate in regulatory inspections and audits. • Prepare regulatory assessments for design changes. • Develop labeling according to applicable regulatory requirements. • Evaluate and communicate regulatory impact of ECOs and design changes across QA and RA domains.

Lead the Product Management function across multidisciplinary development teams, driving best-in-class product ownership methodologies from concept to launch. Act as the strategic commercial bridge between global field teams and R&D, evaluating business needs for ROI and strictly enforcing R&D intake phase-gates to manage WIP limits. Own and author the Product Requirements Document (PRD) & Marketing Requirements Document (MRD), seamlessly translating complex clinical and business workflows into definitive technical product specifications. Drive usability engineering and human factors testing (IEC 62366-1) specifically tailored for complex medical aesthetics devices Cross-Functional Collaboration with system Engineering, Hardware, Software, V&V, Clinical and Regulatory teams to ensure product vision is executed without scope & feature creep. Play a pivotal role in shaping innovative, broad, and technologically advanced medical products. Ensure alignment between product management and regulatory/clinical/quality requirements. Recruit, mentor, and manage a high-performing team of Product Managers / Product Owners as the department scales Standardize product management frameworks, methodologies (for PRDs/MRDs), and lifecycle processes within the R&D division

As an Integration System Engineer in the Imaging Technologies team, you will own the end‑to‑end integration of a multidisciplinary medical device, from early design through validation and release.

You will lead system-level bring-up, define and execute integration strategies, and ensure robust interaction between mechanics, electronics, optics, and software.

This role emphasizes hands-on integration, performance analysis, and cross-functional alignment to deliver a high-quality, production-ready scanner.


Key Responsibilities

System Integration Ownership
Own system integration across all subsystems (mechanics, electronics, optics, software) and ensure a stable, testable, and scalable product.
Lead system bring-up, integration flows, and configuration management across development stages.
Identify interface gaps, define integration requirements, and drive closure with relevant teams.

Performance & Testing
Design and execute system-level experiments to evaluate performance, stability, and reliability.
Develop tools and automation for data collection, analysis, and debugging.
Define integration and verification test strategies, including acceptance criteria and coverage.

Problem Solving & Debug
Lead root-cause analysis of complex cross-domain issues.(HW/FW/SW/optics interactions).
Drive containment, corrective actions, and long-term fixes.
Ensure issues are resolved with clear documentation and learning capture.

Cross-Functional Leadership
Work closely with R&D disciplines, QA/RA, and manufacturing to align on system behavior and requirements.
Translate system-level needs into actionable specifications and integration plans.
Act as the technical focal point for integration-related decisions and trade-offs.

Process & Methodology
Establish and improve integration processes, methodologies, and best practices.
Introduce new tools, capabilities, and approaches to increase integration efficiency and quality.
Ensure proper documentation of integration flows, configurations, and test results.

Team Leadership & Mentorship
Mentor junior engineers and guide student contributors.
Assign and review tasks with a strong focus on quality, rigor, and engineering discipline.

We are seeking a highly motivated and experienced Production and Suppliers Quality Engineer to drive exceptional product quality, patient safety, and field reliability across the Installed Base (IB). This is a key technical role supporting production stability, RMA/DOA investigations, Automated Test Equipment (ATE) performance, and cross-functional quality engineering initiatives in a regulated medical device environment.

Key Responsibilities

In this role, you will:

Support qualifications and control of ATE testers in V&V phase and production lines.

Support ECO/ECR processes, NPI projects, product updates, and cross-functional engineering changes.

Participate in supplier selection and conduct suppliers audits.

Work closely with R&D, engineering, manufacturing, and operations teams to enhance product quality and resolve technical issues.

Drive continuous improvement initiatives using tools such as Six Sigma, Lean, and Root Cause Analysis (RCA).

Support RMA/DOA processes and continuous reduction of field failures.

Ensure compliance with ISO 13485, FDA 21 CFR 820, MDR, and other applicable medical device regulations.

Maintain and support quality documentation, including CAPA, Non-Conformance Reports (NCRs), and risk management documentation.

We are looking for an excellent Research Engineer to join the R & D team.


Job Description:

Lead novel research in state-of-the-art technologies - bypass technological borders.

Lead departmental tasks that include problem solving and critical/root cause analysis.

Algorithms development for various system components.

Design and implementation of experiments for various projects.

Manage mutual research projects done and universities around the world.

We are looking for an excellent Research Engineer to join the R & D team.

Job Description:
Lead novel research in state-of-the-art technologies - bypass technological borders.
Lead departmental tasks that include problem solving and critical/root cause analysis.
Algorithms development for various system components.
Design and implementation of experiments for various projects.
Manage mutual research projects done and universities around the world.


Direct Manager: Research director.

Job Description:

supplier approval/disapproval including supplier maintenance and issuance of the Approved Supplier List.

Leading the SCARS process including SCAR initiation, SCAR follow up, Supplier investigation approval including root cause analysis and SCAR closure.

Leading the supplier audits process (including initial and surveillance audits) for critical suppliers, service centers, laboratories etc. by conducting on site / remote audits. Issuance and execution of the supplier audits plan including supplier audits follow up and supplier non-conformance follow up and response approval.

Support the execution of service agreements, quality agreements with suppliers and service centers.

Leading the supplier score card process, including trending.

Serve as Eitan Medicals CAPA Coordinator and Subject Matter Expert
Responsible and accountable for CAPA ownership, timely execution, and effectiveness of CAPAs. This includes creation, collaboration with functional teams on Problem Statement writing/Scope identification/Risk Assessment/Containment/Correction/CAPA plans/Verification of local and global compliance to CAPA procedures to ensure timely effective closure of CAPAs.

Generate data and key quality trending information for use in periodic reviews like Quality Metric Reviews and Management Review for CAPA and supplier processes.

Work within, and ensure adherence to Quality System procedures, work instructions and other Quality System requirements.
Write, update, release, and sign quality documentation within the Quality management system.

Direct manager: QA Compliance Manager

We are expanding! We are an Israel-based fully integrated pharmaceutical company with multi-national operations. Our BD team is growing and is seeking an individual with strong a strong scientific background in evaluating life science companies, who is also familiar with the biopharma industry at large, and specifically as it pertains to the development and regulatory process. A successful candidate will be able to map and scientifically evaluate pharmaceutical products (approved or in development) in therapeutic areas of interest, assess their market potential and help in building business cases towards licensing deals, investments and other collaborations.
Key Responsibilities:
Identify products and opportunities that are aligned with our growth strategy.
Run scientific evaluation based on mechanisms of action, treatment algorithm, patient journey, market trends, development landscape and competitive analysis and IP.
Engage directly with biopharma companies in Israel and abroad to drive the BD process.
Build business cases and present them internally and to biopharma companies of interest.
Work with internal stakeholders together with external experts during the evaluation and business case processes.
Build and nurture strong relationships with key opinion leaders, healthcare professionals, and other stakeholders.