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Senior Project Engineering Manager

2 months ago


Mildenhall, Suffolk, United Kingdom Select Recruitment Specialists Ltd Full time £35,000 - £45,000

Senior Project Engineering Manager

Select Recruitment Specialists Ltd is proud to present an exciting opportunity for a Senior Project Engineering Manager.

Our client is a prominent player in the field of medical technology, dedicated to the development of groundbreaking devices that significantly enhance healthcare outcomes and patient care.

Key Responsibilities

In the role of Senior Project Engineering Manager, you will play a crucial part in steering the project team through various development phases and ensuring the creation of essential technical documentation to transition innovative medical devices from initial concept to market-ready products.

  • Assisting in the preparation of documentation necessary for regulatory submissions of medical devices.
  • Overseeing project schedules and managing the workload of the project team.
  • Creating project documentation in compliance with ISO 13485 and other relevant medical device regulations.
  • Collaborating with vendors and subcontractors to fulfill project requirements.
  • Conducting risk assessments and hazard evaluations.
  • Formulating product testing methodologies and performing data analysis to validate product safety and compliance.
  • Adhering to all regulatory standards and quality management systems pertinent to medical devices.
  • Occasional travel may be required to meet project demands.

Qualifications

The ideal candidate for the Senior Project Engineering Manager position should possess:

  • Demonstrated experience in the medical device development sector.
  • A degree in Bioengineering or a related medical field, or equivalent professional experience.
  • Experience in managing projects, preferably within the medical device industry.
  • Familiarity with medical device regulations (such as UKCA, MDR, FDA).
  • Understanding of risk management processes in design and development.
  • Strong documentation skills and proficiency in MS Office applications.

Work Schedule: Monday to Friday

This is a remarkable opportunity to join a forward-thinking team and contribute to advancements in the medical technology sector.