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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 expected to 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:
- To provide support with generating documentation relating to the technical file for regulatory submission of the medical products.
- Managing project timelines and project team workloads.
- Generating project documentation in line with ISO 13485 and other medical device regulatory requirements.
- Working closely with the customer to gather relevant concept information.
- Work closely with the design team to create a device that meet the customer’s needs.
- Attend and organise regular internal and customer meetings.
- Engaging with relevant vendors and subcontractors to support the needs of the project.
- Risk management and hazard analysis activities.
- Developing product test methods, basic data analysis/ evaluation to determine or prove product conformance and safety.
- To function within all regulatory requirements and quality systems, particularly related to medical devices.
- Occasional UK travel may be required to satisfy the needs of the project. Guidance, support and/or training will be provided to assist carrying out these responsibilities. As a medical device manufacturer, our design and development processes comply with ISO 13485 requirements.
- This position will require organisational and communication skills (verbal and written), problem solving skills, cross-functional teamwork and the ability to work independently.
The PRINCIPALPROJECT ENGINEER would have:
- Minimum of 2yrs practical experience within medical device development field.
- A Bio Engineering/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.).
- Knowledge of design and development risk management processes.
- Documentation writing skills and ability to use MS Office programs
The typical hours of work will be Monday to Friday 0730 - 1600, but our client can be flexible to suit. The salary range offered is £38,000 - £43,000 per annum.
