Senior Design Assurance Engineer
- Experience Level
- Experienced (non-manager)
They have been around 12 years and were funded by investors initially and then a global Pharma company acquired them and now they are firing on all cylinders, hiring in Germany and US as well as UK and Ireland. Company currently around 70 people, 45 of those in Galway and next year they are looking to add another 50% by hiring 20 more people in Galway alone. They have one product on the market here that is CE marked, approved in the US Oct, 2018 and moving towards approval in APAC!
Their technology aims to replicate nature, as such, their stent is a helical shape, designed to mimic the natural geometry of the vascular system. This is genuinely ground-breaking in the stent world which has previously been governed by tired technology in one if the biggest killers in the world - heart disease. Rather than being situated in the heart it is designed to be in the leg to help prevent clots and keep things moving - the shape is designed to encourage blood to swirl through.
They are fully funded, having a product on the market and having development plans in place for the next 5-10 years all in the space of a year.
They are also looking into having a drug on board as well to create a combination product... watch this space!
You will work as part of one of the development teams on the development of the new stent platforms. You will mostly work on projects to introduce or improve products for treatment of a range of peripheral arterial disease states. Design Assurance is integrated with the product development process; as such, you will support the company’s product development and commercialisation strategy.
- Circa 5 years experience in medical device, ideally within stents and stend coating technology. (Class III medical device).
- Understanding of ISO 13485, ISO 14791 and FDA QSRs.
- Experience with statistics, validation and physical testing.
- Experience with DES is desirable.
Interviews will likely be conducted remotely, always in line with Covid-19 guidelines.