Senior Project Manager

2 weeks ago


Mildenhall, Suffolk, United Kingdom Select Appointments Full time
Principal Project Engineer

Select Appointments is delighted to recruit on behalf of our client, a leading medical device manufacturer. Our client specializes in creating innovative devices that enhance medical treatment and improve patient wellbeing.

Key Responsibilities

A principal project engineer will play a crucial role in leading the project team, generating technical documentation, and ensuring regulatory compliance. Key responsibilities include:

  1. Providing support with generating documentation for regulatory submission of medical products.
  2. Managing project timelines and team workloads.
  3. Generating project documentation in line with ISO 13485 and other medical device regulatory requirements.
  4. Engaging with vendors and subcontractors to support project needs.
  5. Conducting risk management and hazard analysis activities.
  6. Developing product test methods and performing data analysis to determine product conformance and safety.
  7. Ensuring compliance with regulatory requirements and quality systems, particularly related to medical devices.
  8. Occasional travel within the UK to satisfy project needs.

Guidance, support, and training will be provided to assist in carrying out these responsibilities. Our design and development processes comply with ISO 13485 requirements.

Requirements
  • Proven experience in medical device development.
  • A Bioengineering/Medical-based degree or equivalent qualification/experience.
  • Project management experience, ideally in medical device projects.
  • Knowledge of medical device regulations (UKCA, MDR, FDA, etc.).
  • Design and development risk management processes.
  • Documentation writing skills and MS Office proficiency.
Position Details
  • Job Title: Principal Project Engineer
  • Working Days: Monday to Friday
  • Salary: £35,000 - £45,000 per annum based on experience levels

This is an excellent opportunity to join a dynamic team and contribute to the development of innovative medical devices.



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