Design Assurance Lead Osborne is partnering with one of our lead medical devices manufacturing company based in Bray and we are looking for a hands-on Design Assurance Lead to join our greenfield Continuous Glucose Monitoring (CGM) program.
This is a rare opportunity to own end-to-end design assurance from concept through commercialization while working closely with cross-functional teams, R&D, and regulatory stakeholders.
You will be the single accountable quality voice for a product that will make a real impact on patients lives.
Key Responsibilities: Lead Design Controls across the product lifecycle, ensuring robust design and documentation.
Manage Design History Files (DHF), Design & Risk Management Plans, and V&V protocols for regulatory submissions (510(k), CE MDR).
Drive phase-gated design reviews, compliance readiness, and traceability across the V-model.
Support design transfer to manufacturing with validated processes and DMR integrity.
Collaborate with Regulatory Affairs, suppliers, and Notified Bodies as needed.
Train project teams on Design Controls, V&V, and good documentation practices.
Who Were Looking For: Bachelors (or Masters) in Biomedical Engineering or related field.
810 years experience in medical device NPI & sustaining engineering, including 23 end-to-end NPIs in EU/US markets.
Deep knowledge of ISO 13485, ISO 14971, IEC 62304, IEC, FDA QSR 21 CFR 820, EU MDR, MDSAP.
Experience with CGM or wearable devices highly desirable.
Strong communicator, analytical thinker, and proactive problem-solver.
Professional certification (e.g., ISO 13485 Lead Auditor) is a plus.
Why Join Us? Lead a greenfield project with significant autonomy and accountability.
Be part of a passionate, patient-focused team delivering life-changing medical devices.
Onsite role with close collaboration across Quality, R&D, and PMO teams.
Apply Now and take ownership of our next-generation CGM solution Salary €70k/yr To be considered for this position apply today or call Vishnu Singh on.
If you are interested in finding out more about the above role and would like to be considered for this or other suitable roles that we may have available for your skill set please attach your CV via the link provided.
Please submit your updated CV in Word Format.
If you are living in Ireland and hold a VALID WORK PERMIT, we would love to hear from you, if however, you do not hold a valid work permit unfortunately we will not be in a position to assist you with your job search.
Osborne are proud to be an Equal Opportunity Employer #INDOSB1 #INDSINGH