About the role
The Product Development Engineer, shall provide support for the development of innovative medical devices, as part of the R&D team. This position is primarily responsible for the management of clinical investigations and the review and preparation of documentation packages for notified bodies, FDA, and competent authorities.
● Support for management of clinical investigations
● Review and preparation of documentation packages for FDA submissions, and competent authorities.
● Communicate and collaborate w/ study team including internal and external parties, sponsors, and PI
● Preparation of Clinical Evaluation Plan and Clinical Evaluation Report
● Set up and follow up of post-market clinical follow-up
● Master of science, engineering or equivalent.
● Good understanding of medical devices environment
● Very good command of English (writing and speaking) and French or Dutch.
● Preferably 2 years of relevant experience in Medical Devices companies.
● Preferably experienced in submitting clinical trials to ethical committees.
● Detail oriented and meticulous in all aspects of work
● Strong follow through skills and ability to proactively identify and solve problems; demonstrated initiative is imperative
● Ability to work well independently as well as in team environment
● Experience in tele-medicine medical device is a plus.
We offer you
● A permanent position with a competitive package in a fast-growing start-up in a booming sector
● A full-time position
● A stimulating working environment within a team of enthusiastic entrepreneurs
● Working on a technology that will revolutionize healthcare and will positively impact society
Send your CV and a motivation letter to the attention of R&D Manager Amin Hossein, by e-mail at
[email protected] and [email protected]
HeartKinetics is a digital health company, specializing in medical solutions and dedicated to the remote screening and monitoring of patients with heart failure. Created in 2019, HeartKinetics began in the space field thanks to technology for monitoring the heart function of astronauts during their stay in space. Building on the results obtained as part of this ESA-funded project, HeartKinetics now aims to revolutionize the management of heart failure, the leading cause of death worldwide with nearly 65 million cases recorded.
By combining the accessibility of new technologies using only a mobile application, the precision of personalized medicine in real time (digital patient data management platform) and the power of artificial intelligence, HeartKinetics offers a solution fully integrated with the ultimate goal of intercepting the disease in patients at risk of developing heart failure even before the first symptoms appear.