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 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.
Don’t see the position you’re looking for? We would still love to hear from you!