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.

About the Job

We are looking for an energetic and positive Administrative Manager to join our HR team.

Reports to: Director of HR.

Responsibilities

In this role, you will be responsible for all administrative tasks in the office:

• Office management and various administrative tasks related to operations, logistics, and facilities.

• Assist employees and visitors with travel arrangements, including flights and accommodation, and prepare expense reports.

• Maintain kitchen inventory, place supermarket orders, and manage office supplies.

• Assist with planning and execute various HR activities such as employee welfare, gift-giving, happy hours, holiday celebration, and company events.

• Address employee queries regarding office management.

• Provide general support to visitors.

• Provide administrative assistance to the CEO.

• Assist in the onboarding process of new employees.

This is a temporary role for 8 months, serving as a maternity leave replacement.

 

Qualifications

• Minimum of 3 years of experience in a similar or relevant role – must

• Bachelor’s/master’s degree in a relevant field – must.

• Proficiency in Microsoft Office suite – must.

• Experience in a startup company – an advantage.

• Excellent communication and interpersonal skills, with a positive attitude and ability to work well within a team.

• Ability to work independently.

• Positive and proactive approach with a “can-do” attitude.

• Strong attention to detail and problem-solving skills.

 

    Resume*

    About the Job

    We are currently seeking a pre-clinical associate who will participate in in-vivo studies performed with the Company’s products, both locally and abroad (work-related travel up to 50% abroad).

    Reports to: Sr. Director of Pre-Clinical

    Responsibilities

    • Perform and monitor animal studies for both R&D and pre-submission/submission activities.

    • Document and report online information during studies.

    • Maintain accurate records of all testing data and results in the specified forms (paper and electronic) in accordance with the company’s guidelines.

    • Handle biological tissues and blood samples.

    • Provide general assistance in pre-clinical assignments.

    Qualifications

    • VMD in Veterinary Medicine – must.

    • Ability to travel periodically for 1-2 weeks at a time – must.

    • Ability to work nights periodically for 1-2 weeks at a time – must.

    • Two years of experience with pre-clinical studies – advantage.

    • Dedication and proactiveness, with the ability to complete tasks in urgent and stressful situations.

    • Highly creative, adaptive, and flexible thinker.

    • Excellent proficiency in English (oral and written).

    • Strong ability to handle complex situations.

      Resume*

      About the Job

      We are currently looking to hire an experienced QMS Compliance Leader to join our QA group and lead and manage all QMS compliance, monitoring, and analysis activities.

      Reports to: Director of QA

       

      Responsibilities

      Document Control Management:

      • Manage all documentation control processes and serve as the Administrator of “Dot Compliance” (an eQMS implemented in Magenta Medical).

      • Maintain critical company documents, such as SOPs, Training Records, Design Files, Validations, Device History Files, and Device Master Records.

      • Manage documentation and engineering change control process.

      • Maintains current and accurate files for all DHFs and Technical Files.

      • Manage training for personnel to ensure effective and compliant execution of document change control.

       

      CAPA Management:

      • Leads CAPA activities including analysis of data and trends in complaints, supplier quality, nonconforming material, training effectiveness, and root causes analysis.

      • Participate in all aspects of the corrective/preventive action system (CAPA).

      • Provide guidance/training to personnel performing CAPA activities.

       

      Training Management:

      • Responsible for managing company training program: mapping company training needs, training plan, and employees training files and competencies matrix.

      • Preparing QMS training materials, performing QA orientation training for new employees, perform ongoing QA general training.

       

      QMS Monitoring:

      • Quality Management Process monitoring and analysis per measurable process indicators.

      • Implementation of QMS SW tools: assist with mapping and selection of a QMS management software solution (Define and document requirements, implement the use of a QMS SW tool into the Magenta Quality System and revise procedures accordingly, perform validation of the software tool, and write a report).

      • Perform Internal Audits and supplier audits, as required.

      • Prepare and lead Management Review activities.

       

      Complaints Management:

      • Manage and implement the complaints handling process in the company, from initiation, through investigation and closure.

       

      Qualifications

      • B.A. or B.S. degree in a technical discipline, such as Engineering or Science.

      • 5+ years of relevant experience in the medical device industry.

      • Previous experience with medical device verification/validations, ECOs, medical device statistics.

      • Working knowledge of medical device international standards.

      • Ability to work independently with minimal work direction and in a cross-functional team environment.

      • Fluent in English with excellent writing skills, effective written and verbal communication skills.

      • Excellent computer skills, including a working knowledge of Microsoft Office applications.

      • Strong time management abilities to ensure timely task completion.

      • Detail-oriented.

       

        Resume*

        About the Job

        We are looking for an experienced Quality Assurance Specialist to join our QA Operations group and support the variety of activities related to QA Operations.

        Reports to: QA Manager

        Responsibilities

        • Lead QA Operations activities with regards to verifications/validations for an FDA reviewed complex, multidisciplinary, active investigational device.

        • Lead and perform the Engineering Change Order (ECO) process from risk analysis through protocol approval.

        • Verification, execution, and analysis of reposts until FDA-ready.

        • Provide guidance to the R&D and Engineering teams on IQ/OQ/PV activities.

        Qualifications

        • B.A. or B.S. degree in a technical discipline, such as Engineering or Science.

        • 5+ years of relevant experience in the medical device industry.

        • Previous experience with medical device verification/validations, ECOs, medical device statistics

        • Working knowledge of medical device international standards.

        • Ability to work independently with minimal work direction and in a cross-functional team environment.

        • Fluent in English with excellent writing skills, effective written and verbal communication skills.

        • Excellent computer skills, including a working knowledge of Microsoft Office applications.

        • Strong time management abilities to ensure timely task completion.

        • Detail-oriented.

          Resume*

          About the Job

          We are looking for a Supply Chain Coordinator to join our Supply Chain Group.

          Reports to: Supply Chain Manager.

          Responsibilities

          Design and lead NPI processes such as:

          • Open, track, and update work orders for production.

          • Manage the supply chain schedule: collaborate with various teams to receive updates and schedules.

          • Plan inventory levels according to the production plan.

          • Set priorities for QC (receiving inspection).

          • Coordinate production changes with line managers, R&D, and engineering team.

          • Coordinate sterilization processes.

          • Manage the supply chain schedule: collaborate with various teams to receive updates and schedules.

          • Serve as the purchasing coordinator for R&D.

          Qualifications

          • Bachelor’s degree in Supply Chain Management, Logistics Industrial Engineering, Business Administration, or a related field – must.

          • Experience with ERP Priority – must.

          • Fluent in English – must.

          • Prior experience in logistics or supply chain coordination – an advantage.

          • Excellent communication and interpersonal skills.

          • Ability to work in a fast-paced and dynamic environment.

          • Self-motivated and proactive.

           

            Resume*

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