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 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 to hire a Quality Design Assurance Engineer to join our QA team.
As a Design Assurance Engineer, you will lead all quality elements of Design Controls and product DHF for new product introductions and sustaining/design projects.
Reports to: QA Manager
Responsibilities• Quality responsibility to verify that the design and development process follows the procedures and design and development plans.
• Work closely with R&D and test teams to support regulatory requirements by creating, reviewing, and providing quality and compliance input to the design and development process, deliverables, and requirements.
• Participation in project meetings to review and help update clear and concise user requirements, product specifications, plans, verification and validation studies, risk management files, and other relevant design control deliverables.
• Quality responsibility for transferring new products and sustaining projects to manufacturing and operations quality and supplier quality teams.
• Support the Regulatory Affairs department for submissions and respond to submission questions, implementation of new or revised standards and support internal and external audits.
Qualifications
• At least 2-3 years of experience working in a quality function in the medical device industry – must.
• At least 1 year of experience as a design control engineer (preferred).
• A Bachelor of Science in Engineering, Sciences, or a related field – must.
• Familiar with statistical techniques used in verification and validation processes – must.
• Experience with ISO 14971, 21 CR 820, ISO 13485, EU MDR, IEC 60601-1, IEC 62366, and IEC 62304 standards – must.
• Strong analytical and problem-solving skills, with keen attention to detail.
• Excellent communication and interpersonal skills, with the ability to collaborate effectively across functions.
• Proficient use of standard MS Office applications.
• Fluent in English (oral and written).
We are looking for a highly motivated engineer with experience in both software validation and lab work to join our dedicated team.
Reports To: Project Manager
Responsibilities
• Participate in testing activities of the mechanical and clinical aspects of the company’s products, with a focus on V&V bench tests of products and R&D prototypes.
• Conduct and coordinate product testing under defined conditions to verify or reject product specifications using scientific methodologies.
• Perform product testing on components and systems during the 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, Biotechnology, Electrical, and Electronics or another engineering degree – must.
• Hands-on laboratory experience – must.
• Software testing experience – an advantage.
• Understanding of test protocols – an advantage.
• Experience in data analysis – an advantage.
• Experience with CAD software, especially SolidWorks – an advantage.
• Strong ability to follow written and verbal instructions in both English and Hebrew.
• Precise data collection, recording, and reporting capabilities.
• Strong attention to detail.
Don’t see the position you’re looking for? We would still love to hear from you!