Careers

An exciting startup with an innovative contact-free, remote physiological (health) monitoring technology is looking for an experienced cloud development team leader.

Job Description

• The candidate will be an integral part of the clinical team and support clinical research and R&D activities associated with the development of a new and innovative medical device.
  • Perform basic medical tests using our device and other devices in hospitals, clinics, and office
  • Conduct laboratory experiments and assist with laboratory activities, as required
  • Perform and record validation tests of company devices
  • Take part in the training of research teams

  At least 80% of work will be onsite

Education

• Technician/Practical engineer diploma in medicine/ biology/ physics/ biotechnology or in related science area – an advantage.

Required Experience & Skills

• English & Hebrew – professional working proficiency or above
• Proficiency with Microsoft Office (Word, Excel, PowerPoint)
• Able to commute to clinical sites
• Knowledge of medical terminology – an advantage
• Basic knowledge of MATLAB/ Python – an advantage
• Working in a startup environment – an advantage
• Minimum of 1-year experience in clinical research – an advantage
• Proficient with Electronic Data Capture systems – an advantage
• Valid Good Clinical Practice (GCP) certification – an advantage
• Experience in using an ultrasound device – an advantage

Required Personal Skills

• Excellent teamwork skills and good human interface
• Able to work independently and in a team environment
• Positive attitude, responsible, dependable, and dedicated
• Self-motivated, organized, and a problem solver who demonstrates knowledge of fundamentals but also sees the big picture
• Consistent attention to detail and good problem-solving & organizational skills
• Ability to learn new technologies

Looking for an awesome CRA to join our growing Clinical Team in an exciting MedTech start-up, Donisi Health.

A multi-award-winning company, Donisi Health, developed the world’s first FDA-cleared technology that remotely detects multiple key health parameters simultaneously and can provide indications for heart failure exacerbation (as well as additional biomarkers) – from the convenience of a patient’s home, free from wires, patches, and wearables.

The CRA position will help to support clinical research activities associated with the development of a new and innovative medical device and will be responsible for clinical, technical, and administrative tasks to ensure the integrity of clinical data in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).

Role and Responsibilities:

• Conduct site visits including but not limited to validation visits, initiation visits, monitoring visits, and close-out visits
• Document clear, comprehensive, and accurate visit & non-visit contact reports appropriately and in a timely manner
• Create and maintain appropriate documentation regarding site management, monitoring, visit findings, and action plans by submitting regular visit reports, generating follow-up letters, and other required study documentation
• Ensure copies and/or originals of site documents (as required) are available for filing in the Trial Master File (TMF)
• Verify that the Investigator’s Site File (ISF) is maintained in accordance with GCP and local regulatory requirements
• Communicate with the clinical site staff how to coordinate and manage the research activities
• Maintain documentation files and database of clinical investigation projects
• Verify that the study staff is adequately trained
• Conduct additional training for study staff as needed
• Work with sites to adapt, drive, and track subject recruitment plans in line with project needs to enhance predictability.

50-70% of work will be onsite.

Required Experience & Skills:

• English: professional working proficiency or better
• 1-3 years of experience in clinical research
• Working knowledge of GCP/ICH and investigational product regulations
• Knowledge of medical terminology
• Experience in operation/project management
• Very good interaction with patients/customers
• Proficient with Electronic Data Capture systems and Microsoft Office (Word, Excel, PowerPoint) to support the effective conduct of the clinical studies
• Must have a car, valid driver’s license, and the ability to commute to clinical sites
• Working in a startup environment – an advantage
• Experience in the cardiovascular or pulmonary space – an advantage

Required Personal Skills

• People skills: excellent team player and strong interpersonal skills (bedside manner)
• Consistent attention to detail
• Strong problem-solving & organizational skills
• Agile and out-of-the-box thinking mindset
• Sense of urgency and ability to take A-Z ownership of projects and responsibilities

Looking for an awesome V&V Team Lead to join the multi-award-winning and exciting MedTech start-up, Donisi Health.  Donisi developed the world’s first FDA-cleared technology that remotely detects multiple key health parameters simultaneously and can provide indications for heart failure exacerbation (as well as additional biomarkers) – from the convenience of a patient’s home, free from wires, patches, and wearables.

Responsibility

Reviewing business and technical specifications to write and execute manual test scripts for quality assurance testing.

Defining test strategy, executing test plans, reviewing tests product specifications, and participating in defining/selecting appropriate test tools and automation strategy. work closely with SW/HW Program Management, and Operations to test and roll out the releases. Handle and support dynamic schedules, multiple environments, test cycles, and deployments.

R&R:

• Create detailed, comprehensive, and well-structured V&V test protocols and reports, with the ability to maintain and cross-reference it with Risk Analysis Matrix & Design Control documentation.
• Develop, apply & maintain test methods, equipment and instruments for the medical device throughout all development and production stages of the product to meet user needs & product requirements.
• Being involved in the reliability and integration tests for prototypes and products.
• Maintain relevant chapters of DHF & DMR.
• Review specifications and technical design documents to provide timely and meaningful feedback for V&V activities.
• Owner & maintain company’s V&V dept.
• 70% hands-on 30% team lead
• Development and implementation of methodologies for collecting and analyzing field failure data and determining the root cause of field failures
• Coordinating failure analysis with other disciplines as necessary to lead to determination of root cause.
• Ensuring corrective actions are implemented in manufacturing to prevent recurrence of failure.
• Incorporating automation and improvement of the failure analysis process.

Required Experience & Skills:

• 3 Years of proven V&V LEAD experience in the medical device industry – a must
• Knowledge and experience with Medical Device Quality Systems, ISO 13485, FDA/CE submission – a must
• Excellent command of English (verbal and written communication) – a must
• Strong emphasis on problem-solving and effectively prioritizing and executing tasks in a high-pressure environment
• Strong technical orientation for understanding a multi-disciplinary system that includes a device (HW/SW), mobile app, and cloud infrastructure.

Required Personal Skills

• Multi-tasker
• Independent
• Punctual and accurate with excellent organizational skills
• Team-oriented, collaborative, good personal relationships.