דרושים » מדעים מדוייקים » Experienced Verification Engineer

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לפני 18 שעות
Location: Petah Tikva
Job Type: Full Time
We are looking for a Validation & Verification clinical engineer to join our team. As part of the role, you will work closely with R&D to specify, execute, and report the required tests, as well as with QA / RA to ensure that the medical QMS complies. In this role, you will play a key role in ensuring the quality and reliability of our products through rigorous testing and validation. A strong technical background, excellent problem-solving skills, and the ability to work collaboratively with various teams are required for this role.

Key Responsibilities
BSc degree in System, Mechanical, Electrical or Biomedical Engineering or related field.
Develop planning of verification activities, ensuring compliance with regulatory standards and company quality objectives.
Developing test methods for test clinical verification and validation.
Develop the test development processes including designs, reviews, implementations, and test execution.
Continuously improving testing methodology, best practices, and standards to provide consistent testing across products.
Work closely with other teams to build and maintain clinical testing.
Work collaboratively with others to drive best practices.
Requirements:
4-6 years of experience in conducting V&V activities of Medical devices, including writing, and executing test plans and protocols for medical devices with a strong emphasis on QA/RA and problem-solving.
Experience with multi-disciplinary medical device companies.
Strong technical background, and understanding of complex systems including processes.
Formal and practical knowledge of testing methodologies including design and implementation of test protocols, test harnesses tools, infrastructures, and test automation.
Excellent written and verbal communication skills.
Demonstrated knowledge of global quality and regulatory environment for medical devices including FDA CFR 21 part 820.30 and IEC 60601-1-1 (CE mark), ISO 13485, and risk management requirements and development dependencies.
Fluency in English - written and spoken.
This position is open to all candidates.
 
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8727509
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לפני 18 שעות
Location: Petah Tikva
Job Type: Full Time
Daily duties include reviewing business and technical specifications to write and execute automated and manual test scripts for quality assurance testing.
The candidate will be responsible of defining test strategy, execute test plans, review tests product specifications and participate in defining/selecting appropriate test tools and automation strategy.
This function will work closely with HW Development, Program Management, and Operations team to test and roll out the releases.

Key Responsibilities
You will be required to support a variety of corporate business applications and web based products in a QA environment.
Handle and support dynamic schedule, multiple environments, test cycles and deployments.
Responsible for verification and validation tests plans with the ability to maintain and cross-reference it with risk analysis matrix
Develop and maintain test methods, equipment and instruments for medical device throughout all development and production stages of the product
Performing validation and testing of hardware (mechanical, electronic implantable devices) and SW for prototypes and products.
Leading projects to develop and coordinate testing procedures for prototypes and products
Design, selection and documentation of test equipment (HW).
Formulates test guidelines, Acceptance Tests procedures, protocols, and tests reports.
Responsible for specification, purchasing and maintenance of laboratory test equipment.
Participate and lead engineers in designing features and requirements
Introduce the team to new technologies relevant to their current challenges and to the future challenges of the product.
Requirements:
University graduate (B.sc or higher) in mechanical engineering or Biotechnology Engineering.
Above 2 years of relevant experience in the filled of development.
Multi-tasker, independent, punctual and accurate with excellent organizational skills.
Team oriented, collaborative, good personal relationships.
Can conform to shifting priorities, demands and timelines through analytical and problem-solving capabilities.
Ability to effectively prioritize and execute tasks in a high-pressure environment.
Capable of overseas subcontractors management-Advantage.
Hands on experience on jigs testing -Advantage.
Software experience with C++, PYTHON , FPGA- advantage.
This position is open to all candidates.
 
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