Our Mildenhall based client specialises in developing and manufacturing an array of devices that improve medical treatment and patient wellbeing. On their behalf, we are looking for a PRINCIPAL PROJECT ENGINEER to join their team.
As a PRINCIPAL PROJECT ENGINEER you will be expectedto take an integral role leading the wider project team in the development activities and generation of the required technical documentation to bring new medical devices from concept, through regulatory approvals and into commercial products.
A PRINCIPAL PROJECT ENGINEER'S main responsibilities include:
1. To provide support with generating documentation relating to the technical file for regulatory submission of the medical products.
2. Managing project timelines and project team workloads.
3. Generating project documentation in line with ISO 13485 and other medical device regulatory requirements.
4. Working closely with the customer to gather relevant concept information.
5. Work closely with the design team to create a device that meet the customers needs.
6. Attend and organise regular internal and customer meetings.
7. Engaging with relevant vendors and subcontractors to support the needs of the project.
8. Risk management and hazard analysis activities.
9. Developing product test methods, basic data analysis/ evaluation to determine or prove product conformance and safety....