CorWave is a medical technology startup, developing biomimetic implantable heart pumps with the goal of improving the survival and daily lives of patients with heart failure. The CorWave pump with undulating membrane is a disruptive technology protected by over 50 patents and 20 years of research. Funded by leading international investors, supported by renowned surgeons, with more than 70 employees of more than 10 different nationalities, CorWave aims to become a global leader. The “EPIC” values are at the heart of the company’s success and drive CorWavers in this scientific, medical, industrial and profoundly human adventure: Each other together, Persist with passion, Innovate for patients and Cultivate trust.
The V&V Engineer, is responsible to design, develop and qualify product verification and validation test methods to demonstrate a product consistently meets specifications.
Your responsibilities will cover the following :
- Develop and execute design verification and validation protocols based on system requirements and approved procedures and standards (ISO, IEC and FDA).
- Identifies all tasks required to complete project assignments according to Design Control procedures
- Proposes technical solutions and schedule to carry out projects on a timely basis.
- Design and build test fixtures, including support test fixture maintenance and calibration.
- Create, analyze, and summarize documentation related to verification and validation results for internal reviews and regulatory submissions
- Supervise and perform inspection, assembly, and V&V testing to product requirements
- Assist in the development of design input requirements and test designs.
- Assist in writing and reviewing Standard Operating Procedures and Work Instructions
- Interact with and manage external suppliers/vendors especially related to V&V testing
- Assist to define, develop, and implement processes and technical solutions to support current product designs, optimize manufacturing, reliability, and improve quality.
Engineer’s Degree (biomedical, mechanics or mechatronics) and at least three years of relevant work experience (preferably in medical device development).
In order to succeed in this position, you have the following skills and experience:
- Working knowledge and experience with Verification and Validation
- Familiarity with drafting standards and geometric dimensioning and tolerancing
- Familiarity with ISO13485 and FDA 21CFR820
- Knowledge of statistical analysis methodologies for product testing
Professional, concise, tactful and sensitive in communications, you are able to diplomatically negotiate with a requester regarding a design, process, scope or timetable.
You speak and write fluent English, you are able to interact in a multicultural environment. With a strong team spirit, autonomy, rigor and a positive spirit, you are the V&V Engineer that CorWave is looking for.
Compensation and logistics
- Position to be filled as soon as possible
- Competitive salary based on skills and experience
- Executive (cadre) status with day package
- Contact type: full-time permanent contract (CDI)
- Location: Paris area, Clichy-Levallois (métro ligne 13, train L 6 min de Saint Lazare)
- Food allowance with a Swile card
- 50% reiumbursement of your Navigo pass & bike bicycle mileage costs
- Health insurance (« complémentaire santé ») Malakoff Humanis
- Complementary collective insurance scheme (« prévoyance »): Malakoff Humanis (100% funded by CorWave)
- International environment
- Onsite interviews with the hiring manager and a team member + workshops
- HR & VP interview
- Interview with the CEO
- Reference check
Please send your CV to: firstname.lastname@example.org, reference « V&V EN ».