Please send applications to [email protected]
JEB Technologies is looking for an enthusiastic principal project engineer to join their rapidly growing team in medical device development. JEB Technologies specialise in developing and manufacturing an array of devices that improve medical treatment and patient wellbeing. At JEB Technologies, a principal project engineer is 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.
Responsibilities:
– 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 meets 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.
Qualifications and Experience:
This position will require organisational and communication skills (verbal and written), problem-solving skills, cross-functional teamwork and the ability to work independently.
The principle project engineer would have:
– 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.
Department: Medical
Position type: Permanent, full time
Location: Mildenhall, Suffolk
Salary: Negotiable- dependent on experience
Please send applications to [email protected]