An exciting opportunity to join an incredibly innovative start up based in Galway. My client is looking for an R&D Lead to join their growing start-up company to set the technical direction of the company.
- As R&D Lead you will set the technical direction of the organisation and lead product development with significant influence and ownership on R&D activities and direction.
- You will be tasked with scoping out the work necessary to complete milestones to get the product approved for patient use.
- Critical to the role will be excellent communication skills, and forming and scaling a team of engineers to meet product development milestones as the company continues its journey to FDA clearance in the coming years and product commercialisation.
- This is a high impact role which will provide serval opportunities for growth including technical learnings, experience working directly with core stakeholders (the patient representatives and clinicians), the opportunity to build a team, and the chance to travel to work with partners and attend relevant conferences.
- Minimum of 8 years’ post qualification experience within a medical device R&D environment.
- Experience with QMS systems applicable to medical devices (21CFR820 & ISO13485)
- Strong technical writing skills necessary to translate to regulatory documentation.
- Demonstrated design and development skills with prototyping flair.
- Demonstrated experience in test method development and the DV&V process.
- Demonstrated experience in design transfer from R&D to manufacture.
- An understanding of the regulatory process for both pre-clinical & clinical trials.
- Electronics experience & experience with fluids in medical devices advantageous.
For a confidential discussion and more information on the role please contact Rhys Joyce.