Senior Project Manager

1 month 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 based in the UK. Our client specializes in creating innovative medical devices that enhance treatment and improve patient wellbeing.

Key Responsibilities

The successful candidate will play a key role in leading the project team in development activities and generating technical documentation to bring new medical devices from concept to commercial products. 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 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.
  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 client's design and development processes comply with ISO 13485 requirements.

Requirements

The ideal candidate will have:

  1. Proven experience in medical device development.
  2. A Bioengineering or Medical-based degree or equivalent qualification/experience.
  3. Experience in project management, ideally of medical device projects.
  4. Knowledge of medical device regulations (UKCA, MDR, FDA, etc.).
  5. Knowledge of design and development risk management processes.
  6. Documentation writing skills and proficiency in MS Office programs.
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 make a significant impact in the medical device industry.



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