Senior Design Assurance Engineer (Contract)
Location: ATU iHubs, Galway
Who are we?
SymPhysis Medical are an early-stage start-up focused on developing patient solutions in the area of palliative care. Our initial technology platform is a catheter-based device used to treat the build up of fluid in the body as a result of late-stage cancers.
Over the past 5 years our founders, who are passionate about developing patient-centred products, have built strong and lasting relationships with partners that have helped fast-track the development of their disruptive releaze™ device. As a result of this success and momentum, we are looking to secure a contract role for the business in the capacity as Senior Design Assurance Engineer to join our Team based in Galway.
The Opportunity
We are seeking a highly experienced Senior Design Assurance Engineer to collaborate on design verification activities and ensure regulatory compliance for submission to FDA in 2026. The ideal candidate will have deep expertise in DV testing, sterilization validation, technical documentation, and regulatory submissions (FDA), and will be able to contribute immediately with minimal onboarding.
The Successful Person will be responsible for:
Design Verification & Validation
- Collaboration in Design Verification (DV) test protocols, including for sterilization.
- Collaboration in Test Method Validations (TMVs) for DV testing.
- Oversee and coordinate biocompatibility testing and ensure alignment with ISO 10993 standards.
- Support and review pre-clinical, clinician and patient usability studies.
Documentation & Regulatory Compliance
- Collaborate, review and approve all R&D-generated documentation for FDA submission.
- Collaborate and assist in the preparation of documentation for eSTAR FDA submission, ensuring completeness and accuracy.
- Ensure compliance with relevant standards (e.g., ISO 13485, ISO 14971, IEC 62366).
Cross-functional Collaboration
- Work closely with Quality, R&D, Clinical, and Regulatory teams to ensure design assurance activities are aligned with project timelines and regulatory expectations.
- Provide expert input during build completion for DV & V activities.
The successful person will be comfortable working closely with all levels within the organisation along with external stakeholders and will effectively deliver product solutions which benefit our customers.
Our Vision & Goal
Our vision is to provide ‘Independence through Innovation’ for people requiring palliative care and to build a scalable Irish business focusing on providing quality of life. With our core clinical ties in Ireland we are also working with some of the top cancer centres in the US. Our global ambition is to expand into multiple therapeutic areas where we can apply our technology to improve patients’ quality of life, reduce hospital costs and help enable patient independence.
By working closely with our clinical, academic and manufacturing partners in the coming years, we will be completing design freeze, pre-clinical and clinical trials, human factors studies, DV&V and FDA regulatory submission with the target of launching in the US market following with Europe shortly after.
Apply for this position
If you are interested in joining our expanding team, please contact our HR Department by emailing your CV and cover letter to:
hr@symphysismedical.com
Think you don’t meet all the requirements? Talk to us anyway! We would love to hear from you.
