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Job Type: Full Time
A medical device company is seeking to hire a Quality Design Assurance Engineer to join our QA team. As a Design Assurance Engineer, you will lead all quality elements of Design Controls and product DHF for new product introductions and sustaining/design projects.
Responsibilities
Quality responsibility to verify that the design and development process follows the procedures and design and development plans.
Work closely with R D and TEST teams to support regulatory requirements by creating, reviewing, and providing quality and compliance input to the design and development process, deliverables, and requirements.
Participation in project meetings to review and help update clear and concise user requirements, product specifications, plans, verification and validation studies, risk management files, and other relevant design control deliverables.
Quality responsibility for transferring
Requirements:
At least 2-3 years of experience working in a quality function in the medical device industry - must.
At least 1 year of experience as a design control engineer (preferred).
Prior hands-on experience in Verification Validation (V V) activities within the medical device industry - a significant advantage.
A Bachelor of Science in Engineering, Sciences, or a related field - must.
Familiar with statistical techniques used in verification and validation processes - must.
Experience with ISO 14971, 21 CR 820, ISO 13485, EU MDR, IEC 60601-1, IEC 62366, and IEC 62304 standards - must.
Strong analytical and problem-solving skills, with keen attention to detail.
Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
Proficient use of standard MS Office applications.
Fluent in English (oral and written
This position is open to all candidates.
 
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הגשת מועמדות
עדכון קורות החיים לפני שליחה
8680382
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2 ימים
Location: Petah Tikva
Job Type: Full Time
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.
Requirements:
Core Technical Skills
B.Sc./M.Sc. in Electrical, Mechanical, Biomedical, Computer Engineering, or similar.
5+ years of experience in system integration, system engineering, or multidisciplinary R&D.
Strong hands-on experience in system bring-up, testing, data analysis and debugging.
Experience analyzing system performance using Python / MATLAB / similar tools.
Solid understanding of HW-SW interfaces and electromechanical systems.
Experience with lab equipment, test setups, and automation frameworks.

Integration & Systems Thinking
Experience integrating complex multidisciplinary systems (preferably medical devices or imaging systems).
Ability to define test strategies, experiments, and validation approaches.
Strong troubleshooting and root-cause analysis capabilities across system boundaries.

Collaboration & Leadership
Proven ability to lead cross-functional efforts without formal authority.
Strong communication skills with the ability to present technical findings clearly.
Experience mentoring or leading junior engineers / students.

Nice to Have
Experience with optical systems or imaging technologies.
Familiarity with regulated environments (FDA / CE, design control, V&V).
This position is open to all candidates.
 
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הגשת מועמדותהגש מועמדות
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2 ימים
Location: Petah Tikva
Job Type: Full Time
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.
Requirements:
Bachelors degree in Engineering (Mechanical, Electrical, Biomedical, or related field).

3+ years of experience in Quality, medical device experience is a strong advantage.

Strong analytical and problem-solving skills, including hands-on experience with RCA tools (5-Why, Fishbone, etc.).

Familiarity with ATE systems, production testing, and/or field reliability analysis - a strong advantage.

Working knowledge of ISO 13485, FDA 21 CFR 820, and ISO 14971 risk management.

Excellent communication and collaboration skills, with the ability to work effectively across functions.

A proactive, structured, and detail-oriented working style.

Fluent in English.
This position is open to all candidates.
 
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הגשת מועמדותהגש מועמדות
עדכון קורות החיים לפני שליחה
עדכון קורות החיים לפני שליחה
8727558
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