Principal Project Engineer

· 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 information.

· Work closely with the design team to create a device that meets the customers' 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, basis 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.

Are you the type of person who gets a thrill out of medical device development, but also thinks that a day without multitasking is a day wasted? Do you dream in project timelines and technical jargon? Well, put on your lab coat and grab your coffee (or tea, we don't judge), because we've got the job for you!!, · A Bio Engineering/Medical based Degree or equivalent qualification.

· Practical experience within medical device development field.

· 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.

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