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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)

Reports to: to: VP QA/RA

Job Description

As the Quality Engineering Manager, you will work closely with multiple teams working on and being responsible for the development, implementation, and maintenance of the ENvizion’s Quality Management System and related programs.  The incumbent in this position must have detailed working knowledge of common QMS models including ISO 13485 and the FDA’s Quality System Regulation.  Demonstrated leadership skills and ability to make risk-based decisions are core requirements.  Position is a member of the company’s Management Review Team.

Required Education, Experience and Skills:

• BSc in engineering discipline
• 8+ years of combined quality assurance, quality engineering and regulatory compliance management in the medical device industry including direct experience with software-based medical devices.
• Minimum of three years’ experience in a quality management role within a medical device company.
• Significant experience participating and leading regulatory audits.
• Ability to link technical and systems strategies into the overall business strategy for the company.
• Excellent interpersonal skills working across multiple divisions and sites and external resources.
• Excellent written and verbal communication skills.
• Excellent skills in managing both internal and outsourced technical resources.

Reports to: Senior Software Engineer

Job Description: 

As a Software Engineer you will participate in the entire software development life cycle, including design, documentation, implementation, testing & debugging of a medical device product.

Duties and Responsibilities:

• Plan, design and develop well-engineered, robust, high-quality software solutions
• Collaborate with cross-organizational teams to implement technological decisions and guidelines

Required Education, Experience and Skills:

• BSc in Computer Science / Mathematics or equivalent
• Experience in developing object-oriented applications under Windows environment
• Proficient in C#
• Experienced in C++ an WPF – an advantage
• Highly motivated team player, mathematical thinking owner
• Technical curiosity and fast learning new fields
• Excellent spoken and written English
• Experience with 3D graphic development – an advantage

The primary role of this position is to plan and execute the testing of a multidisciplinary medical product to ensure quality throughout the software development lifecycle.

Responsibilities:

• Perform software verification and validation tests for medical device system
• Review software requirements and provide input to ensure testability
• Plan and execute tests to mitigate risk (performance and functional testing)
• Write bug reports and present findings to R&D and business teams
• Manage software testing documentation

Required Education, Experience and Skills:

• BSc in Engineering (preferably Biomedical)
• At least 2 years’ experience in SW Testing of a multidisciplinary product (HW and SW)
• Experience with bug tracking systems (such as JIRA)
• Knowledge in DevOps (versions management, continuous integration, etc.)
• Fluent in Hebrew and English

Reports to: Complaints Investigations Engineer

Job Brief:

The Complaint Investigation Specialist supports the product complaint program including initial complaint assessment and identification of complaints related to adverse events. Analyzes incoming product complaints, determines requirements for investigation, investigates and evaluates complaints, and finds solutions together with cross-functional team to customer issues.

Duties and Responsibilities:

• Records and evaluates complaint submissions.
• Communicates with health care providers (HCP), HCP staff and/or patient to acquire relevant complaint information.
• Coordinates with internal departments (Customer Service, Regulatory Affairs, Quality Assurance,
• Medical Affairs, Manufacturing and R&D) to incorporate vital input into medical device event reports.
• Track receipt, investigation and closure of product complaints to ensure adherence to established timelines.
• Ensures timely processing of complaints.
• Investigate complaints and subsequently document the evaluation actions taken and conclusions reached using the defined report template.
• Where possible identify the root cause of the complaint and facilitate identification and implementation of corrective and preventive actions relative to a complaint investigation.
• Submit Quality Notification Reports to management for expedited complaints.
• Track and trend complaints, including provision of trend reviews / reports to customers, site and corporate management, and for Annual Product Records Reviews.
• Assure regulatory compliance of the complaint program is maintained.
• Support operations and quality management initiatives and objectives

Requirements

• Degree in Biomedical or Mechanical Engineering
• Prefer Candidates who have experience ~ testing medical devices in a medical device or biotech company.
• Previous experience working in a regulated environment and following SOP’s is a plus.
• Ability to work at a fast pace while maintaining quality work is also a plus.
• In addition, ability to perform routine / repetitive work.
• Candidates without previous industry experience will also be considered

Job description

Reports to: VP Clinical Affairs

• Work from Tel-Aviv office (Non-Hybrid work)
• Job requires travels to the US!

Job Brief:

We are looking for an experienced CTM to join our clinical team and take part in planning clinical trials, site qualification and initiation, interim and post clinical monitoring, site management in US and Israel, writing and submitting clinical documents and result analysis.

Duties and Responsibilities:

• Serve as a liaison between ENvizion Medical and the study site, investigators, study coordinators, and staff members
• Coordinate activities to set up and monitor a study from site initiation to study closeout (including preparation of study plans, budget, clinical sites coordination, etc.)
• Prepare ethical submissions, study documents (protocols and informed consent forms, case report form) and investigator brochures for clinical studies
• Perform monitoring visits as well as remote data monitoring
• Create and review monitoring visit reports
• Perform training visits at clinical sites
• Verify that the investigator(s) and study staff/coordinators are trained and follow the approved protocol and Good Clinical Practice
• Having high understanding of the product
• Present at feeding tube placement procedures using the ENvue system

Requirements

• BSc/MSc Degree in Life Sciences, Nursing or Biomedical Engineering
• CRA certificate
• At least 5 years’ experience as a CRA/CTM in a medical device company
• Knowledge of standards and regulation of clinical trials in USA, Europe and Israel
• Knowledge of computer systems for managing and reporting clinical studies (eCRF)
• Ability to analyze data and write test reports
• Strong team player skills
• Excellent presentation and communication skills – in Hebrew and English