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Open Positions at ENvizion Ltd. (Israel)

Open Positions at ENvizion Inc. (US)

Job Description

The Mechanical Engineer will participate in the design and characterization of innovative medical device as well as assist with product testing and validation

Duties and Responsibilities:

  • Participate in the mechanical design and development of the company’s products
  • Generate solid models, drawings and specifications
  • Prepare and execute tests to verify the design and the performance
  • Provide technical assistance in R&D activities

 

Position Requirements:

  • BSc in Mechanical Engineering
  • 3 years’ experience as a Mechanical Engineer in the medical device industry
  • Proficiency in 3D CAD software (preferably Solid Edge)
  • Excellent communication skills and problem-solving ability
  • Fluent English (both written and spoken)

Job Description

The role of the QA/RA manager is to provide leadership and take ownership of quality assurance activities in Envizion Medical Israel office and contribute to the global QA/RA team effort to ensure compliancy to the company’s Quality Management System.

Duties and Responsibilities:

  • Serve as the primary interface to external service providers executing quality assurance and regulatory compliance activities on behalf of the Company
  • Ensure the maintenance and improvement of ENvizion’s QMS, which includes the following: Design Control, Document and Change Control, Management Review, Internal Audit, Corrective and Preventive Action, Complaint Handling and Adverse Event Reporting, DHR Review and Product Release, Non-Conforming Product, Process and Software Validation.
  • Provide ongoing review of QMS execution activities to ensure that all QA and RA compliance programs meet applicable regulations and standards
  • Provide training to company personnel on QMS related topics.
  • Host and conduct external audits:
    • Perform site and/or supplier audits.
    • Host regulatory, client and notified body audits.
  • Manage Quality Engineering activities to ensure compliant documentation for the follow elements of the design control process:
    • Design and Development Planning
    • Design Input / User Needs Documentation
    • Verification and Validation Plans, Protocols and Reports
    • Design Review documents (plans, agendas, minutes, action item follow-up)
    • System Specifications
    • Software Requirements Documents
    • Software Design Documents
    • Design Transfer Plans / Reports
    • Risk Management Plans / Reports
    • Risk Analyses
    • Traceability Matrices
    • Software Risk Classification
  • Lead engineering Change Control Boards, as necessary to ensure change planning and impact assessments are performed and documented appropriately.
  • Define and provide metrics on the performance of the Design Control and Risk Management processes.

Required Education, Experience and Skills:

  • BSc in Engineering (Mechanics/Electronics/Computers/Biomedical)
  • At least 10 years of experience in the medical device industry – in Quality Engineering or Quality Assurance roles
  • Experience in a Quality management role
  • Knowledge of common QMS models including ISO 13485 and the FDA’s Quality System Regulation
  • Significant experience in participating and leading audits
  • Demonstrated leadership skills and ability to make risk-based decisions
  • Excellent, clear communication in Hebrew and English
  • Extremely detail oriented
  • Ability to travel abroad

Location: Indiana 

Job Description:

The Clinical Education Specialist will provide clinical demonstrations for use of ENvizion products in evaluation, implementation and on-site procedures. Demonstrations could be in formal educational settings as well as small‐group or individual presentations in patient‐care areas throughout a healthcare facility, to facilitate broad adoption of ENvizion products and technology.

The Clinical Education Specialist will play a key role in assisting the sales team in the acquisition of new business and the care and maintenance of existing customers.

Duties and Responsibilities:

  • Generate and provide clinical demonstrations and education programs for the use of ENvizion products in evaluation, implementation and on-site procedures
  • Work with Marketing to develop and deliver standardized onboarding and training materials for all ENvizion products
  • Work with customers to introduce, promote, and increase the usage of ENvizion products throughout a customer facility
  • Provide installation, related in‐service education and integration to new clients to ensure customer satisfaction
  • Maintain awareness of medical and scientific literature to increase expertise related to the company’s products to perform as a subject matter expert
  • Serve as a company’s liaison on clinical matters regarding the ENvizion products and provide information/feedback to the R&D and Marketing teams
  • Represent the company and act as a course facilitator/presenter at various trade shows, training programs and events (including KOL development programs)
  • Prepare the equipment, materials and supplies for all education programs
  • Maintain all Certifications and necessary Hospital Vendor Credentialing

 

Required Education and Experience:

  • At least a bachelor’s degree – a combination of life sciences/clinical degree (BSc) with a business/marketing education (MBA) is preferable
  • At least 3 years of experience providing clinical support in Endoscopy, Operating Room or Special Procedures, preferably with intra-body navigation technologies
  • Remote-based position; must travel (minimum of 75%)

Required Skills:

  • Strong interpersonal skills and ability to interact effectively with different groups
  • Excellent written and verbal communication skills including public speaking, presentation and training skills
  • Excellent project management and organizational skills
  • Ability to prioritize and manage multiple tasks
  • Ability to solve problems and provide effective solutions
  • Proactiveness and ability to act with autonomy and independence

Location: California

Job Description:

The Clinical Education Specialist will provide clinical demonstrations for use of ENvizion products in evaluation, implementation and on-site procedures. Demonstrations could be in formal educational settings as well as small‐group or individual presentations in patient‐care areas throughout a healthcare facility, to facilitate broad adoption of ENvizion products and technology.

The Clinical Education Specialist will play a key role in assisting the sales team in the acquisition of new business and the care and maintenance of existing customers.

Duties and Responsibilities:

  • Generate and provide clinical demonstrations and education programs for the use of ENvizion products in evaluation, implementation and on-site procedures
  • Work with Marketing to develop and deliver standardized onboarding and training materials for all ENvizion products
  • Work with customers to introduce, promote, and increase the usage of ENvizion products throughout a customer facility
  • Provide installation, related in‐service education and integration to new clients to ensure customer satisfaction
  • Maintain awareness of medical and scientific literature to increase expertise related to the company’s products to perform as a subject matter expert
  • Serve as a company’s liaison on clinical matters regarding the ENvizion products and provide information/feedback to the R&D and Marketing teams
  • Represent the company and act as a course facilitator/presenter at various trade shows, training programs and events (including KOL development programs)
  • Prepare the equipment, materials and supplies for all education programs
  • Maintain all Certifications and necessary Hospital Vendor Credentialing

Required Education and Experience:

  • At least a bachelor’s degree – a combination of life sciences/clinical degree (BSc) with a business/marketing education (MBA) is preferable
  • At least 3 years of experience providing clinical support in Endoscopy, Operating Room or Special Procedures, preferably with intra-body navigation technologies
  • Remote-based position; must travel (minimum of 75%)

Required Skills:

  • Strong interpersonal skills and ability to interact effectively with different groups
  • Excellent written and verbal communication skills including public speaking, presentation and training skills
  • Excellent project management and organizational skills
  • Ability to prioritize and manage multiple tasks
  • Ability to solve problems and provide effective solutions
  • Proactiveness and ability to act with autonomy and independence

Apply Now