Mildenhall, Suffolk
Select Recruitment Specialists are delighted to recruit on behalf of our client based in Mildenhall, Suffolk. Our client is a leader in medical device development, specialising in creating innovative devices that enhance medical treatment and improve patient wellbeing.
Role & Responsibilities
At our client’s company, a principal project engineer is expected to take an integral role in leading the wider project team in development activities and generating 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:
- Providing support with generating documentation relating to the technical file for regulatory submission of 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.
- Collaborating with the design team to create devices that meet the customer’s needs.
- Attending and organising regular internal and customer meetings.
- Engaging with relevant vendors and subcontractors to support project needs.
- Conducting risk management and hazard analysis activities.
- Developing product test methods and performing basic data analysis/evaluation to determine or prove product conformance and safety.
- Functioning within all regulatory requirements and quality systems, particularly related to medical devices.
- Occasionally travelling within the UK to satisfy project needs.
Qualifications & 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 principal project engineer should 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.).
- Knowledge of design and development risk management processes.
- Documentation writing skills and the ability to use MS Office programs.
- Job Title: Principal Project Engineer
- Working Days: Monday to Friday
- Salary: £35,000 - £45,000 per annum based on experience levels