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Senior Medical Device Engineer

2 months ago

Mildenhall, Suffolk, United Kingdom Select Appointments Full time
Principal Project Engineer

Select Appointments are delighted to be working with a leading medical device company based in the UK. Our client is renowned for creating innovative devices that enhance medical treatment and improve patient wellbeing.

Role & Responsibilities

A principal project engineer is expected to lead the project team in development activities and generate the required technical documentation to bring new medical devices from concept, through regulatory approvals, and into commercial products.

  • Provide technical support with generating documentation relating to the technical file for regulatory submission of medical products.
  • Manage project timelines and project team workloads.
  • Generate project documentation in line with ISO 13485 and other medical device regulatory requirements.
  • Engage with relevant vendors and subcontractors to support project needs.
  • Conduct risk management and hazard analysis activities.
  • Develop product test methods and perform basic data analysis/evaluation to determine or prove product conformance and safety.
Requirements

The ideal candidate will have:

  • Proven practical experience within the medical device development field.
  • A Bioengineering/Medical-based degree or equivalent qualification/experience.
  • Experience in project management (ideally of medical device projects).
  • Knowledge of medical device regulations (UKCA, MDR, FDA, etc.).
  • Documentation writing skills and the ability to use MS Office programs.

Select Appointments offer a competitive salary of £35,000 - £45,000 per annum based on experience levels.