CorWave

About the Company

CorWave is a French company developing innovative cardiac assist
devices.

CorWave’s wave membrane pump is a breakthrough technology that
differs from today’s commercially available left ventricular assist devices
(LVADs) by its physiological operation, designed to mimic a pulse and
blood flow rates similar to those of a healthy heart. Ultimately,
CorWave’s membrane pump technology is expected to reduce the
complications associated with current devices and improve the
management of heart failure patients.

A member of the French Tech 120, CorWave was founded in 2012 by start-up studio MD Start and is funded by renowned investors including Bpifrance, Exor Ventures, EIC Fund, Financière Arbevel, M&L Healthcare, Novo Holdings, Seventure Partners, Sofinnova Partners, Ysios Capital and Vlerick Group. The company has secured over €80 million in equity and employs over seventy people.

Listed Jobs

Company Name

CorWave

Job Title

Quality Assurance Engineer

Job Description

Job Offer

Contract: 12-month Fixed-Term Contract (Full-Time)

Location: Clichy (Metro Line 13 or Line 14, RER C, Train L, Bus 74 or 341...)

Benefits: Meal vouchers (€8.50 per working day), health insurance (50% employer coverage), provident insurance (100% employer coverage), transport pass (50% employer coverage), and 25 days of paid vacation per year.

Start date: May 2024.

Company Description

CorWave is a medical technology startup developing biomimetic implantable heart pumps with the mission of improving the lives of patients suffering from advanced heart failure.

The CorWave pulsatile membrane pump is a groundbreaking technology protected by more than 50 patents and the result of 20 years of research.

Backed by leading international investors and supported by renowned surgeons, CorWave aims to become a global leader.

More than 90 CorWavers from 13 different nationalities are driving this scientific, medical, industrial, and deeply human adventure.

Recruitment Context

Are you looking for a new challenge within an innovative and dynamic company?

Join our committed team, which has transitioned from R&D to cutting-edge industrial production.

Our mission: to design and manufacture ultra-performance, reliable heart pumps dedicated to improving the lives of patients with advanced heart failure.

If you are motivated, ready to innovate, and excel in an agile environment, this adventure is made for you.

Join us, where every heartbeat makes a difference!

Job Responsibilities:

The Quality Assurance Engineer demonstrates quality in all actions:

Ensure compliance to QSR and ISO 13485 requirements
Documents root cause analysis of non-conforming product, in concert with other departments
Reviews and approvals of DMR and DHF documents
Evaluates change orders to ensure accuracy of documentation, appropriate testing is performed, and the appropriate impacts are considered
Review, provide feedback and approve process validations reports (IQ, OQ, PQ) with Operations team
Review, provide feedback and approve design verification and validation reports with Research, Design and Software teams
Works closely with R&D and Operations to support risk analysis activities
Supports creation of QMS according to ISO 13485


Required Knowledge, Skills, Abilities

Must possess good communication (verbal & written) skills and analytical problems solving skills
Strong computer skills in MS Office products (Excel, Word, PowerPoint)
Ability to work effectively in a team environment


Required Education/ Experience

BS Engineering, math or closely related field required
Minimum 5 years experience in QA/RA in medical device manufacturing
Strong working knowledge of QSR and ISO requirements
Demonstrated experience in Risk Analysis, Statistical techniques, FDA, QSR, ISO13485, 21 CFR Part 820
Experience should include competency in evaluating new quality plans


Preferred Experience

Ability to communicate with technical and non-technical personnel
Ability to prioritize/schedule activities to meet department's goals and objectives

Clichy, France

Hybrid

03-04-2025