Come Work With Us!
Magenta is a medical device company developing the world’s smallest heart pump, meant to provide minimally-invasive support to the heart during acute episodes of dysfunction. The Elevate™ System is multi-disciplinary, involving mechanical engineering, material science, electrical engineering, software, algorithms and state-of-the-art catheter fabrication techniques.
We are looking for the best people possible who can help us propel the Elevate™ System forward and save more lives.
We are seeking a talented Clinical Trials Manager to join our Clinical Affairs team.
Executing international multi-center clinical trials, from submission to composing final reports. Leading activities from pre-market clinical trials through post-market evaluations for determination of product safety and effectiveness, in compliance with applicable clinical and regulatory standards and in alignment with company objectives.
Reports to: Vice President of Clinical Affairs.
Responsibilities
• Execute the clinical trial and oversee the clinical trial management team while ensuring trials are compliant with all applicable regulations, company procedures, and ethical/quality standards.
• Management of clinical trial sites/CROs/core labs.
• Develop and manage clinical study plans to complete the clinical trial successfully meeting the milestones within required timelines.
• Work with the CRO to develop eCRF and EDC.
• Preparation of clinical regulatory document packages for IRB/EC submissions in US/EU, as applicable.
• Manage project status and analyze trial performance.
• Anticipate and communicate study risks/issues and lead implementation of the mitigation strategies.
• Preparation of portions of the clinical sections of regulatory submissions and study reports.
Qualifications
• Bachelor’s degree. An advanced degree in life sciences is an advantage.
• At least 7 years of experience managing clinical trials in the medical device Industry.(experience with invasive medical devices – an advantage).
• Proven track record in leading international multi-center studies.
• Experience in interventional cardiology and familiarity with invasive cardiac therapies – an advantage.
• Experience preparing submissions to regulatory agencies globally – an advantage.
• Experience corresponding with regulatory agencies – an advantage.
• GCP certified, CRA- advantage.
Desirable Skills:
• English – full proficiency.
• High verbal and writing skills.
• High self-learning ability.
• Independent and responsible person.
• Strong execution, communication and interpersonal skills.
We are seeking a Software Developer who will have the opportunity to grow and learn while playing a key role in developing software for the innovative Magenta System.
Reports to: Sr. Director of SW and HW Development
Responsibilities
• Design and develop all software aspects of the company’s products.
• Manage software versions and upgrades for existing products.
• Oversee the entire software lifecycle, including development, testing, and documentation.
• Manage external sub-contractors for software development and validation.
• Maintain a system-wide perspective and responsibility for all software components.
• Design, implement, and integrate firmware and user interface (UI).
• Manage software lifecycle development, generate software requirements and specifications, and create all relevant software lifecycle deliverables.
• Conduct design reviews in accordance with company policies.
• Provide input on software usability.
Qualifications- B.Sc. or higher in Computer Science or another Engineering degree – must.
• 3+ years of experience in SW software development – must.
• Proficiency in mixed C/C++ programming – must.
• Proven experience with STM32 microcontroller firmware development, developing for sensors, brushless motors, and stepper motors – must.
• Knowledge of communication protocols (e.g., UART, SPI, I2C) – must.
• Software integration and development with the QT framework and QML – must.
• Knowledge of AWS and Docker architecture, Python, and React – advantageous.
• Experience in the medical device industry – advantageous.
• Strong problem-solving skills & interpersonal skills.
• Excellent written and verbal communication skills.
We are looking for a V&V engineer to join our V&V team.
Reports to: V&V Team Leader
Responsibilities
• Participate in testing activities of the mechanical and clinical aspects of the company products, with focus on V&V bench tests of products and R&D prototypes.
• Conduct product testing activities under defined conditions to verify/reject product specification using scientific methods.
• Perform product testing on items and components that are in R&D phase.
• Develop test methods to support the testing process throughout prototype development and assembly.
• Write protocols and reports detailing testing procedures and results.
• Support animal studies and experiments, including handling biological tissues and blood samples.
Qualifications
• B.Sc. in Biomedical Engineering or Biotechnology – must.
• Hands-on laboratory experience – must.
• Understanding of test protocols – an advantage.
• Experience in data analysis – an advantage.
• Ability to integrate written and verbal instructions, in both English and Hebrew.
• Capability to accurately collect, record, and report data.
• Strong attention to detail.
Don’t see the position you’re looking for? We would still love to hear from you!