Design Assurance Engineer

2 weeks ago

Center District, Israel Magenta Medical Ltd. Full time ₪90,000 - ₪120,000 per year

About the Company

Magenta Medical
is a
Class III medical device company
developing the
smallest and most powerful heart pump in the world
– the
Elevate System
. Designed to deliver
minimally invasive cardiac support
during acute episodes of heart dysfunction, the Elevate System is a
multidisciplinary innovation
, combining
mechanical engineering
,
material science
,
electrical engineering
,
software
,
algorithms
, and
advanced catheter fabrication techniques
.

As we scale up for commercial manufacturing, we're entering a phase of rapid growth.

We're looking for
exceptional individuals
to help us
drive the Elevate System forward
,
build the foundation for long-term success
, and most importantly –
save lives.

.

We're looking for a
Quality Design Assurance Engineer
to join our growing
QA team
. In this role, you'll collaborate closely with
R&D, Configuration, Engineering, and Manufacturing teams
, working across
software, hardware, and mechanical systems
to support design excellence and regulatory compliance.

As we continuously evolve our product and processes toward
PMA (Pre-Market Approval)
, this is a unique opportunity to join at a
high-impact phase
of development.

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 , 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).

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