דרושים » ייצור ותעשייה » Medical device's Design Assurance Engineer -

Requirements:
Must Have:
B.Sc. in Engineering - mandatory; Mechanical Engineering - preferred. 3-5 years of experience in Process Engineering, Manufacturing Engineering, or a similar production engineering role. Proven experience leading engineering/process changes end-to-end, from definition through implementation and closure. Experience with process verification, validation, or qualification activities. Experience working with external suppliers and subcontractors. Strong understanding of manufacturing and assembly processes, and proven hands-on experience supporting production. Practical experience using measurement tools and equipment, and the ability to analyze data. Strong problem-solving, investigation, and root cause analysis capabilities. Fluent English - written and verbal, including technical writing
Advantages:
Experience in the medical device industry. Familiarity with FDA, ISO 13485, or other regulated manufacturing environments. Experience with formal process validation protocols and reports (IQ/OQ/PQ). Experience with manufacturing technologies such as injection molding, sheet metal & machining processes. Experience working with, or qualifying processes at, overseas suppliers and subcontractors. SolidWorks/PDM experience and the ability to read mechanical drawings. Experience with eQMS systems. Experience with Lean Manufacturing / Continuous Improvement methodologies. Computer Skills: Proficiency in Microsoft Office applications, with a good level of Excel for data analysis. Personal Skills: Strong technical and analytical capabilities. Hands-on, practical, and solution-oriented approach. Ability to lead cross-functional processes and drive stakeholders to deliver. Excellent interpersonal and communication skills. Self-motivated and independent. Ability to manage multiple priorities and work effectively under pressure. Team player with a proactive and continuous-improvement mindset.

Requirements:
Must Have:
B.Sc. in Engineering - mandatory; Mechanical Engineering - preferred.
3-5 years of experience in Process Engineering, Manufacturing Engineering, or a similar production engineering role.
Proven experience leading engineering/process changes end-to-end, from definition through implementation and closure.
Experience with process verification, validation, or qualification activities.
Experience working with external suppliers and subcontractors.
Strong understanding of manufacturing and assembly processes, and proven hands-on experience supporting production.
Practical experience using measurement tools and equipment, and the ability to analyze data.
Strong problem-solving, investigation, and root cause analysis capabilities.
Fluent English - written and verbal, including technical writing
Advantages:
Experience in the medical device industry.
Familiarity with FDA, ISO 13485, or other regulated manufacturing environments.
Experience with formal process validation protocols and reports (IQ/OQ/PQ).
Experience with manufacturing technologies such as injection molding, sheet metal & machining processes.
Experience working with, or qualifying processes at, overseas suppliers and subcontractors.
SolidWorks/PDM experience and the ability to read mechanical drawings.
Experience with eQMS systems.
Experience with Lean Manufacturing / Continuous Improvement methodologies.
Computer Skills:
Proficiency in Microsoft Office applications, with a good level of Excel for data analysis.
Personal Skills:
Strong technical and analytical capabilities.
Hands-on, practical, and solution-oriented approach.
Ability to lead cross-functional processes and drive stakeholders to deliver.
Excellent interpersonal and communication skills.
Self-motivated and independent.
Ability to manage multiple priorities and work effectively under pressure.
Team player with a proactive and continuous-improvement mindset.

Requirements:
B.Sc./M.Sc. in Engineering (Biomedical Engineering is an advantage).
3+ years of experience in QA roles.
Excellent technical aptitude and ability to quickly learn complex systems and technologies.
Strong analytical and troubleshooting skills.
Passion for software quality, technology, and healthcare.
Ability to independently drive tasks from planning through execution.
Excellent communication skills in Hebrew and English, both written and verbal.
Thrives in a fast-paced, dynamic startup environment, demonstrating flexibility, initiative, and a proactive approach.
Desirable Skills:
Experience working in regulated environments such as medical devices or healthcare.
Familiarity with test design methodologies and defect management processes.
Curious mindset with a desire to deeply understand systems and investigate issues.
Strong attention to detail, persistence, and a hands-on approach.

Requirements:
B.Sc. in Mechanical Engineering or Biomedical Engineering - Required. 3+ years of experience in mechanical design, including strong SolidWorks skills and experience working with subcontractors - Required 2+ years of experience in the medical device industry - Required. 2+ years of experience with validations and production documentation, including work instructions, routing cards, and ECOs.
* Strong hands-on approach and a passion for turning ideas into working solutions.
* Excellent problem-solving, analytical, and creative thinking skills
* Ability to work independently while being a strong team player
* Proactive, accountable, and detail-oriented approach. Fluent English, both written and verbal.

Requirements:
Education: BSc. in Mechanical Engineering from a well-known university - a must.
Job Skills:
o At least 6 years of proven experience in electro-mechanical product design and development.
o At least 3 years of proven experience in the design and development of precision drive mechanisms - a must.
o Proven track record of mechanical designs from concept through development and into production.
o Strong ability to create and maintain accurate engineering documentation, including concepts, designs, drawings, specifications, and processes.
o Understanding and knowledge of medical device regulations and standards - an advantage.
o Hands-on experience in building, assembling, and testing mechanical components.
Computer Skills:
o Excellent hands-on experience with SolidWorks and PDM.
o Proficiency in Microsoft Office applications.
Language skills:
Fluent English, both written and spoken.
Personal Skills:
o Excellent interpersonal and communication skills.
o Self-motivated and able to work independently.
o Able to perform effectively under pressure.
o Strong team player.

Requirements:
Education BSc. in Mechanical Engineering from a well-known university – a must. Job Skills o At least 6 years of proven experience in electro-mechanical product design and development. o At least 3 years of proven experience in the design and development of precision drive mechanisms - a must. o Proven track record of mechanical designs from concept through development and into production. o Strong ability to create and maintain accurate engineering documentation, including concepts, designs, drawings, specifications, and processes. o Understanding and knowledge of medical device regulations and standards - an advantage. o Hands-on experience in building, assembling, and testing mechanical components. Computer Skills o Excellent hands-on experience with SolidWorks and PDM. o Proficiency in Microsoft Office applications. Language skills: Fluent English, both written and spoken. Personal Skills: o Excellent interpersonal and communication skills. o Self-motivated and able to work independently. o Able to perform effectively under pressure. o Strong team player.

Requirements:
Bachelor's degree in Electrical Engineering, Mechanical Engineering, or a related field.
At least 7 years of experience in electromechanical product development.
Proven leadership experience in managing R&D teams for at least 3 years.
Strong knowledge of electromechanical systems and relevant industry standards.
Experience with project management and budget oversight.
Excellent problem-solving and analytical skills.
Effective communication and interpersonal skills.

Requirements:
Bachelors degree in engineering or a related technical field.
Experience working with electronic, mechanical, or electromechanical products.
Strong understanding of quality management systems and supplier quality processes.
Experience conducting supplier audits and QBRs.
Strong communication and interpersonal skills.
Ability to manage multiple priorities and work independently.
Proficiency in Microsoft Office applications.
Fluent in English (written and spoken).
Preferred Qualifications:
Lead Auditor certification.
CQE (Certified Quality Engineer) certification.
Experience with ERP and PLM systems, priority- advantage.
Experience in high-tech, aerospace, or semiconductor industries- advantage.

Requirements:
Required Knowledge and Experience:
A Bachelor of Science degree in Computer Science or a related field.
At least 4 years of hands-on experience combining test automation and manual software testing.
Practical programming experience in Java or C#.
Strong understanding of Object-Oriented Programming (OOP) principles
Experience working in Agile and Scrum environments.
Solid working experience with core automation technologies, including TestNG, Appium, Git, CI/CD pipelines, and Azure DevOps.
Ability to perform functional, regression, and exploratory testing and communicate test findings clearly.
Experience working with medical software, digital health solutions, or Software as a Medical Device (SaMD) products will be considered an advantage.


Physical Job Requirements:
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position. 

Requirements:
Required Knowledge and Experience:
A Bachelor of Science degree in Computer Science or a related field.
At least 2 years of hands-on experience combining test automation and manual software testing
Practical programming experience in Java or C#
Strong understanding of Object-Oriented Programming (OOP) principles
Experience working in Agile and Scrum environments
Solid working experience with core automation technologies, including TestNG, Appium, Git, CI/CD pipelines, and Azure DevOps
Ability to perform functional, regression, and exploratory testing and communicate test findings clearly.
Experience working with medical software, digital health solutions, or Software as a Medical Device (SaMD) products will be considered an advantage.

Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.