Come Work With Us!
Magenta Medical 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 seeking exceptional individuals to help drive the Elevate™ System forward and potentially 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 looking for a highly motivated and experienced logistics supervisor to join our Supply Chain Group.
Reports to: Supply Chain manager.
Responsibilities
• Manage daily warehouse activities, including goods receipt, inventory management, warehouse organization, work order preparation, equipment organization for clinical trials, and sterilization logistics.
• Oversee goods receipt, ensuring accurate recording and handling of all incoming items.
• Monitor inventory levels and notify relevant personnel when stock falls below the minimum threshold.
• Prepare work orders and assembly kits for the production team, ensuring timely completion and adherence to required standards.
• Warehouse Maintenance – ensure warehouses are consistently clean, organized, and well-maintained
• Equipment organization for clinical trials, ensuring all the equipment is sterilized and is ready for use.
• Manage sterilization logistics cycles to meet operational requirements.
Qualifications
• 3-5 years of experience in warehouse logistics, preferably within medical device companies – must.
• Bachelor’s degree in supply chain management, logistics, business administration, or a related field – must.
• Familiarity with medical device inventory management regulations, traceability, and audits – an advantage.
• Experience with ERP systems, particularly Priority – an advantage.
• Fluent in English – must.
• Excellent organizational and time management skills.
• Ability to work in a fast-paced, dynamic environment.
• Self-motivated and proactive.
We are looking for a talented Mechanical Engineer to join our Engineering team and take the lead on multiple processes and a complex product – making the transfer to manufacturability.
Reports to: Director of Engineering
Responsibilities
Design and lead NPI processes such as:
• Collaborate and share data with R&D, Production, and Quality in integrating and implementing process modification.
• Early engagement with R&D activities and support design updates to be serial-production-worthy documentation.
• Design verification tests- process and fixtures
• Support production with process-based challenges
• Design fixtures and jigs to improve manufacturing processes.
• Lead ECO process and support conformity reports.
• Full control of in-scop product’s BOM, DMR, and documentation.
Qualifications
• B.Sc in Mechanical Engineering-must.
• Recommended three years of experience in the medical device industry.
• Proficiency in Solid works (and PDM).
• Analytical skills.
• Good written/verbal communication skills.
We are seeking to hire a Quality Assurance Assistant.
The assistant will implement and provide ongoing support for document control and other general QMS activities as necessary, in line with our unwavering commitment to quality.
Reports to: QA Manager
ResponsibilitiesDocument Control Activities:
• Operation and maintenance of the eQMS (Electronic Quality Management System) – Dot Compliance.
• Implementation and ongoing support of all Document Control activities.
• Process Document and Engineering Change Orders (DCO and ECO).
• Support and maintain all company Device History Files (DHF) and Device Master Record (DMR).
Qualifications
• Bachelor’s degree in a relevant field.
• At least 3 years of experience in a similar or relevant role.
• Excellent written and verbal communication skills.
• Ability to manage time effectively to ensure timely completion of tasks.
• Proficiency in PC usage, including Microsoft Word, Excel, PowerPoint, and other Office applications.
• Capability to work independently and collaboratively in a cross-functional team environment.
• Highly detail oriented.
• Fluency in English, both written and spoken.
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.
Don’t see the position you’re looking for? We would still love to hear from you!