Senior Manager Verification & Validation Testing (V&V) M/W

29/08/23

Company Description

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 80 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.

Job description

The Verification & Validation (V&V) Senior Manager will lead CorWave’s verification and validation activities in support of product commercialization.

He/She will manage and coordinate the team in charge of validation and verification activities to ensure that the company can demonstrate the critical safety and performance criteria required to initiate clinical studies and ultimately support approval heart pump regulation.

He/she will lead the design, development and execution of product testing, to meet quality, safety and regulatory requirements, including selection and coordination with external testing laboratories.

His responsibilities will include:

  • Design and develop product verification and validation strategies
  • Create, publish and execute test protocols to determine compliance with design requirements
  • Lead the design, qualification and manufacture of test equipment
  • Support the evaluation of prototype designs and the design of test and inspection methods.
  • Manage external suppliers providing services related to verification and validation activities.
  • Manages laboratory testing facilities to ensure efficiency, suitability and safety
  • Leads troubleshooting efforts for issues identified with configuration, protocols, equipment and test execution.
  • Identifies and coordinates efforts to mitigate sub-system and project risks.
  • Accomplishes all of the above while ensuring compliance with the quality system.
  • Supports regulatory submissions as required.

Qualifications

Engineering degree (biomedical, mechanical or mechatronics) and at least 7 years of professional experience in the design, testing or manufacture of medical devices or a similar high precision industry, such as automotive or aerospace.

You ideally have 3 years of experience as a Team Manager.

To succeed in this role, you have the following skills and experience:

  • Familiarity with ISO-13485 design control product development methodology or equivalent quality system
  • Practical experience as a leader in the use of modern testing methodologies/processes with the ability to lead the use of resources to achieve departmental objectives.
  • Experience leading cross-functional and multi-site teams

This would be a plus:

  • Experience in testing compliance with electronic safety standards IEC 60601-1 and 2 and ISO 14708 for active implantable devices

Professional, concise, tactful and sensitive in your communications, your ability to manage teams is demonstrated.

You speak and write fluent English, you are able to interact in a multicultural environment.

You have:

  • Strong organizational skills including attention to detail and multitasking skills
  • Working knowledge of product testing methods and product development life cycle
  • Ability to prepare technical documents that are well structured and easy to understand.
  • The desire to animate, coordinate and maintain team cohesion and motivation.

Compensation and logistics

  • Position to be filled as soon as possible
  • Competitive salary based on skills and experience
  • Contact type: full-time permanent contract (CDI)
  • Location: Paris area, Clichy (métro lines 13 & 14 + shuttles, train L 6 min from Saint Lazare + shuttle)
  • Food allowance with a Swile card
  • 50% reimbursement 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

Please send your CV to: careers@corwave.com, reference « V&V Senior Manager ».