The Company

Sudden cardiac deaths (SCD), also known as sudden cardiac arrest, accounts for 10-15% of all deaths in adults (around 400 000 deaths each year in Europe) equivalent to the cumulative mortality of lung and breast cancers. The paradox is that efficient treatment options exist, such as implantable defibrillators. The major unsolved problem remains in how to non-invasively identify subjects at risk prior to death.

Pulsheart was founded in 2023 by Prof. Michel Haïssaguerre and colleagues from the Liryc research center (150+ international multidisciplinary experts in cardiology) to develop and validate software and hardware to tackle this major screening need, assess early a potential risk and prevent SCD.

The Position

To support PulsHeart growth and ambition to develop game changing medical devices, we are looking for a Senior Test Engineer with strong ethics, willingness to learn, tenacity to solve problems and strong desire to work in a fast-paced multi-disciplinary environment.

As a key member of the R&D team, your mission will be to lead verification and validation (V&V) activities across hardware, software, and system levels. You will play a critical role in ensuring product quality, safety, and regulatory compliance while working closely with Hardware, Software, Quality, and Regulatory teams.

The Mission

Test Strategy & Execution

• Define and own test strategies, plans, and protocols for PulsHeart’s medical device
• Lead system, integration, and verification testing activities
• Design and execute manual and automated test cases
• Ensure comprehensive coverage of functional, performance, usability, and safety requirements
• Provide clear test results and quality insights to engineering leadership and product management

Regulatory & Quality Compliance

• Ensure testing activities comply with Quality and Regulatory standards
• Contribute to Design History File (DHF) artifacts, including test plans, test reports and traceability matrices
• Support risk management activities, including hazard analysis and risk controls verification
• Support audits and regulatory submissions on test aspects

Test Practices & Culture

• Support development and improvement of test automation frameworks, test tools, CI/CD pipeline where applicable (Github, AWS, Jira, Typescript, React)
• Champion good testability practices and act as a quality advocate with engineers, clinicians and leadership
• Drive continuous improvement in test processes and documentation

Skills

• Minimum 5 years experience in V&V role for Class II or Class III device
• Background in both hardware and software testing
• Have been through at least one full medical product development cycle
• Rigor, organization
• Good communication and leadership skills

To Apply

https://jobs.pharmelis.com//fr/apply?job=5359-69&source=linkedin