This role will see you consult with the business as you work with them to review their existing product portfolio and ensure they are set up to meet the requirements of Europe's new Medical Device Regulations (MDR).
Key responsibilities will include:
- Review the gap analysis that has been completed in-house and analyse the existing product portfolio
- Gather the design requirements and define the technical parameters for continued device development and engineering changes including assessing and understanding medical standards and regulations
- Ensure design requirements are met and leading design reviews, direction and solution decisions. This will include working with multiple stakeholders across the business including CAD designers, Product Managers, manufacturing, suppliers and Regulatory Affairs.
- Carry out risk management activities including DFMEA and user risk assessments before implementing control measures
- Direct usability, ergonomic and design validation studies with clinical users, assessing and communicating study results and resolving any issues before producing the associated documentation
- Direct prototype builds, prototype testing and final verification including raising test requests and approving test reports.
- Maintain the design history file ensuring the design changes are detailed and traceable in line with medical industry standards.
To apply for this position send your CV to Kirsty Seymour at Monarch Engineering