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.

Clinical Trial Assistant (CTA)

Magenta Medical - US, Full-time, Remote

We are looking for a proactive and detail-oriented Clinical Trial Assistant (CTA) to join our Clinical and Regulatory Affairs team. In this role, you will provide essential support for the planning, execution, and management of clinical trials. Working closely with the Clinical and Regulatory Affairs team, you'll ensure all activities align with Good Clinical Practice (GCP), regulatory standards, and company protocols. Your efforts will directly contribute to the success of our clinical programs and the advancement of innovative medical solutions. 

Reports to:

Vice President of Clinical and Regulatory Affairs

 Key Responsibilities:

Administrative Support:

  • Maintain and organize essential study documents in compliance with GCP and regulatory guidelines.
  • Assist in the preparation, distribution, and tracking of key study documents (e.g., protocols, Investigator Brochures, Informed Consent Forms).
  • Schedule and coordinate internal and external meetings, teleconferences, and project activities.
  • Assist Case Support Team and Leadership team with special activities as needed.

Regulatory & Compliance:

  • Support the preparation and submission of regulatory documentation to IRBs, Ethics Committees, and other regulatory bodies.
  • Track regulatory approvals and maintain up-to-date site documentation (e.g., CVs, licenses, training certificates).
  • Ensure accurate archiving of study materials during and after trial completion.

Communication & Coordination:

  • Act as a liaison between clinical sites, vendors, case support, and internal teams to address queries and streamline communications.
  • Facilitate collaboration among cross-functional teams and assist in ensuring study timelines are met.

Data & Document Management:

  • Maintain clinical trial tracking tools and databases, ensuring accurate updates on enrollment and milestone progress.
  • Review documents and data for completeness and accuracy in accordance with study requirements.
  • Monitor and track clinical supplies such as investigational products (IP) and related materials.

Quality Assurance:

  • Assist in preparation for audits and inspections by ensuring documentation is complete and compliant.
  • Assist in resolving findings from quality assurance activities or monitoring visits.


Qualifications and Competency:

General Qualification:

  • Bachelor’s degree in Life Sciences, Health Sciences, or a related field- must.
  • GCP or CRA certification (preferred).
  • Research or health care related work experience - preferred.
  • 1–3 years of experience in clinical research or related roles, preferably in the medical device industry.
  • Experience with invasive medical devices is a plus.

Technical Skills:

  • Proficient in Microsoft Office (Word, Excel, Outlook, PowerPoint).
  • Familiarity with Clinical Trial electronic systems.

Key Competencies:

  • Strong organizational and multitasking abilities.
  • Excellent communication skills, both written and verbal.
  • Meticulous attention to detail.
  • Proactive problem-solving and adaptability in a fast-paced environment.
  • Team-oriented mindset and willingness to collaborate.

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Embedded Software Engineer

Magenta Medical - IL, Full-time, On-site

About the Role - 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

  • 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

Reports to:

Sr. Director of SW and HW Development

  • 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


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Mechanical Engineer

Magenta Medical - IL, , On-site

Magenta Medical is a Class III medical device company that develops the smallest and most powerful heart pump in the world. With commercial manufacturing and scale-up on the horizon, we're expanding our Operations and Engineering teams - join us to help build the foundation for success!

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 transition to manufacturability.

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.

• Provide production support by addressing process-related challenges.

• Design fixtures and jigs to improve manufacturing processes.

• Lead ECO process and support conformity reports.

• Full control of the in-scope product’s BOM, DMR, and documentation.



Reports to:

Director of Engineering

• B.Sc. in Mechanical Engineering - must.

• 1-3 years of experience in the medical device industry.

• Proficiency in SolidWorks (and PDM).

• Analytical skills.

• Good written/verbal communication skills.


Why join now?

  • Be part of a startup atmosphere with the ambition for a commercial launch.
  • Play a pivotal role in building our manufacturing systems and processes from the ground up.
  • Work in a cross-functional team that values innovation, ownership, and impact.

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Process Validation Engineer

Magenta Medical - IL, Full-time, On-site

Magenta Medical is seeking an Intermediate Process Validation Engineer to join our dynamic team.

The successful candidate will be responsible for ensuring that manufacturing processes, equipment, and products meet established quality standards and regulatory requirements. This role requires a strong background in process validation methodologies and a collaborative approach to work within cross-functional teams to drive continuous improvement and compliance.


Responsibilities

  • Validate manufacturing processes.
  • Participate in the development of new production processes, including Tech Transfer, PFMEA, PVMP, IQ, OQ, PQ, etc.
  • Develop, execute, and maintain process validation protocols and reports for new and existing products, ensuring compliance with regulatory requirements.
  • Collaborate with cross-functional teams, including R&D, Quality Assurance, and Manufacturing, to design and implement validation strategies.
  • Conduct risk assessments and identify critical process parameters to ensure product quality and consistency.
  • Provide technical support and guidance during audits and inspections related to process validation.

Reports to:

Project Manager

  • Bachelor's degree in Engineering, Life Sciences, or a related field.
  • Minimum of 3 years of experience in process validation within the medical device or pharmaceutical industry.
  • Strong understanding of validation principles, methodologies, and regulatory requirements.
  • Experience with complex mechanical/material production processes (advantageous).
  • Familiarity with Process Validation Master Protocols (PVMP).
  • Knowledge of risk assessment methodologies, including DFMEA and PFMEA.
  • Experience with Test Method Validation.
  • Proficiency in Design of Experiments (DOE) analyses.
  • Experience in writing protocols and reports.

Required Skills

  • Proficiency in CAD software (SolidWorks).
  • Experience with data analysis/statistical software (JMP or MiniTab).
  • Strong problem-solving, analytical, and troubleshooting skills.
  • Ability to collaborate effectively in cross-functional teams.
  • Strong written and verbal communication skills in English.
  • Excellent interpersonal skills.


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Production Engineer

Magenta Medical - IL, Full-time, On-site

We are hiring an experienced Production Engineer to join the engineering group.

As a Production Engineer, you will play a pivotal role in supporting the Production Department by driving effective problem-solving and troubleshooting efforts.

You will be directly involved in the manufacturing processes of one of the company's flagship projects, ensuring smooth and efficient production.

This dynamic role requires a deep understanding of product design, coupled with expertise in both chemically and mechanically oriented manufacturing processes, familiarity with quality management aspects, and the ability to identify and analyze potential risks.

Collaboration is key in this position, as you will work closely with cross-functional teams, including Engineering, Quality, and Operations, ensuring that production runs seamlessly and meets the highest standards.

Reports to:

Director of Engineering

  • A Bachelor’s degree in Mechanical Engineering or a similar field is required.
  • 3-5 years of experience in product lifecycle development in a Medical Device company – familiarity with Design Control Stages is required.
  • 1-3 years of experience in manufacturing processes development, mainly mechanically and chemically oriented processes is required.
  • Knowledge of risk assessment methodologies, DFMEA, and PFMEA.
  • Experience in conducting risk assessments.
  • Familiarity with quality control methodologies – NCRs, CAPA, etc.
  • Experience in writing engineering rationales.


Skills:

  • Acquittance with CAD software, Solid Works
  • Strong problem-solving and analytical skills.
  • Ability to corate in ollabcross-functional team.
  • Strong written skills in English.
  • Excellent interpersonal relationships.

 

Why Join Us?

  • Play a critical role in ensuring product quality and improving production processes.
  • Work on a life-saving Class III medical device.
  • Join a fast-growing startup and contribute to scaling clinical production.

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Quality Assurance Associate

Magenta Medical - IL, Full-time, On-site

We are looking for a Quality Assurance Specialist to join our growing team. In this role, you will be responsible for implementing and supporting document control processes and general quality management system (QMS) activities. This position is crucial to maintaining Magenta’s high standards of quality and regulatory compliance.

Reports to: QA Manager

Responsibilities

  • Operate and maintain the Electronic Quality Management System (eQMS).
  • Oversee and support all Document Control activities, ensuring timely and accurate processing.
  • Manage Document Change Orders (DCOs) and Engineering Change Orders (ECOs).
  • Maintain and update the Device History Files (DHF) and Device Master Records (DMR).
  • Collaborate with cross-functional teams to ensure compliance with internal procedures and regulatory requirements

Reports to:

Reports to: QA Manager

  • Bachelor’s degree in a relevant field (e.g., Life Sciences, Engineering, Quality Assurance).
  • Minimum of 3 years of experience in a similar or relevant quality role within the medical device or life sciences industry.
  • Strong written and verbal communication skills.
  • Highly detail-oriented with excellent organizational abilities.
  • Effective time management skills and the ability to prioritize tasks independently.
  • Proficient in Microsoft Office Suite (Word, Excel, PowerPoint).
  • Comfortable working both independently and within cross-functional teams.
  • Fluency in English, both written and spoken.

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Quality Assurance Engineer

Magenta Medical - IL, Full-time, On-site

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, such as:

  • 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.


Reports to:

QA Manager


  • B.A. or B.S. degree in a technical discipline, such as Engineering or Science. 
  • 3-5  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.


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Regulatory Affairs Associate

Magenta Medical - IL, Full-time, On-site

We are seeking an experienced Regulatory Affairs Associate to join our team.

The Regulatory Affairs Associate will support Magenta’s products from early feasibility through marketing authorization, ensuring compliance with regulatory requirements. This role will work closely with other departments to maintain regulatory adherence and facilitate successful product approvals

 

  • Provide regulatory support for Magenta’s products from early feasibility through marketing authorization.
  • Prepare and maintain regulatory submissions and registrations for Magenta’s products in relevant markets.
  • Conduct technical reviews of data and reports for regulatory submissions to ensure accuracy and clarity.
  • Assess changes to device design or processes to determine their impact on pending or existing registrations.
  • Provide guidance to project teams on premarket regulatory requirements, labeling standards, and other compliance matters.
  • Monitor and communicate updates on new or revised guidance, regulations, and industry initiatives to ensure regulatory compliance.

Reports to:

Vice President, Regulatory Affairs & Quality Assurance

  • Bachelor’s degree in a scientific, technical, or engineering discipline – must.
  • Minimum of five years of Regulatory Affairs experience with the US FDA and EU regulatory agencies (Class II and/or Class III medical devices) – must.
  • Alternatively, candidates with a strong background in Design Quality Assurance seeking to specialize in Regulatory Affairs will be considered.
  • Excellent writing and editing skills.
  • Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
  • Proficiency in standard MS Office applications.
  • Fluency in English, both oral and written

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Research Development Mechanical Engineer

Magenta Medical - IL, Full-time, On-site

Magenta Medical is seeking a motivated Intermediate Research Development Mechanical Engineer to join our innovative team. The successful candidate will play a key role in the design and development of cutting-edge medical devices. You will collaborate with cross-functional teams to drive product development from concept through to production, ensuring compliance with regulatory standards and company objectives.
Responsibilities:

  • Design, develop, and prototype mechanical components and systems for medical devices.
  • Conduct experiments and tests to validate designs and improve performance, ensuring products meet quality and regulatory standards.
  • Collaborate with electrical engineers, software developers, and regulatory teams to create innovative solutions.
  • Prepare technical documentation, including design specifications, test plans, and reports.
  • Participate in design reviews and provide constructive feedback to team members.
  • Assist in troubleshooting and resolving engineering issues during product development and manufacturing.

Reports to:

R&D Team Leader.

  • Bachelor’s degree in Mechanical Engineering or a related field.
  • A minimum of 3 years of experience in mechanical design and development, preferably in the medical device industry.
  • Proficiency in CAD software (e.g., SolidWorks, AutoCAD) and simulation tools.
  • Strong understanding of material properties and manufacturing processes.
  • Familiarity with regulatory requirements for medical devices (e.g., ISO 13485, FDA guidelines).
  • Excellent problem-solving skills and the ability to work collaboratively in a team environment.

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Senior Clinical Research Associate (CRA)

Magenta Medical - US, Full-time, Remote


We are seeking an experienced Senior Clinical Research Associate (Sr. CRA) to oversee clinical trial sites, ensure regulatory compliance, and support site operations.

  • Serve as the primary liaison between trial sites and sponsor teams, resolving site-related issues.
  • Oversee site management, including regulatory submissions, training, and study conduct.
  • Maintain clinical trial documentation in eTMF and CTMS systems.
  • Ensure site compliance with protocols, regulations, and GCP guidelines.
  • Support remote monitoring by reviewing site documentation and resolving queries.
  • Assist in audits and regulatory inspections, ensuring audit readiness.
  • Track and follow up on SAEs, protocol deviations, and safety reporting.
  • Provide site staff training on protocol, GCP compliance, and data entry.
  • Collaborate with cross-functional teams to ensure smooth study execution.
  • Assist in investigator payments, site invoicing, and budget adherence.
  • Mentor junior CRAs and study coordinators.

 

Reports to:

Director, Clinical Trial Management

  • Bachelor’s degree in Life Sciences or related field (MD, MBA, or advanced degrees preferred) – must.
  • 5+ years of clinical research experience, focusing on on-site management and clinical trial support- must.
  • Experience with Class 3 medical devices and/or complex clinical trials.
  • Strong knowledge of FDA, ICH-GCP, and global regulations.
  • Proficiency in CTMS and eTMF systems.
  • Excellent communication, problem-solving, and organizational skills.

Preferred Qualifications:

  • Clinical Research Associate certification (CCRA).
  • Experience with regulatory submissions and audits.
  • Knowledge of risk-based monitoring and site engagement strategies.

Key Competencies:

  • Strong organizational and multitasking abilities.
  • Excellent communication skills, both written and verbal.
  • Meticulous attention to detail.
  • Proactive problem-solving and adaptability in a fast-paced environment.
  • Team-oriented mindset and willingness to collaborate.

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Technician

Magenta Medical - IL, Full-time, On-site

We are expanding our manufacturing operations and recruiting assembly technicians for our production team.

Our unique manufacturing process is conducted in a controlled environment using a variety of production technologies

Responsibilities:

  • Manufacturing Activities Device assembly for clinical use in the controlled environment area (clean room).
  • process for Magenta’s products and per Magenta’s procedures and Work Instructions including the handelling of chemical materials.
  • Cleaning components and equipment before entering the controlled environment area (clean room)
  • Cleaning and maintenance of Clean Room.
  • Fine assembly work under a microscope.
  • Perform all required manufacturing, inspection and packaging activities along the production.

Reports to:

Production Director

  • Experience working in a Controlled Environment Area (Clean room).
  • Understanding of assembly instructions and drawings.
  •  Previous experience in a medical device company or the healthcare field is an advantage.
  • Attention to details.
  • A team worker, well orgenized.

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Don’t see the position you’re looking for?

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