Clinical Trials and Validation Systems Engineer

6 days ago


Basingstoke, Hampshire, United Kingdom Blatchford Full time
About the Role

Blatchford, a leading manufacturer of advanced prosthetic technology, bespoke seating solutions, and orthotic devices, is seeking a highly skilled System Engineering Manager - Clinical Trials & Validation to join our dynamic R&D team at our Head Office in Basingstoke.

Key Responsibilities
  • Lead the development and execution of clinical evaluations and studies for company products, identifying key performance indicators (KPIs) and creating comprehensive reports.
  • Define and drive the implementation of the R&D clinical team's roadmap to achieve superior clinical outcomes.
  • Contribute to quality improvement processes and review/approve technical documentation in accordance with our Quality Management System (QMS).
  • Ensure effective technical leadership and communication of project status to management and peers.
  • Manage allocated budget and resources.
What We Offer
  • A highly competitive salary.
  • Flexible, hybrid working arrangements.
  • 25 days' holiday (rising with service) and the option to purchase additional annual leave.
  • A comprehensive pension scheme.
  • Death in service benefit.
  • Discounted shopping and leisure activities.
  • A health cash plan.
  • A cycle to work scheme.
  • The opportunity to be part of an award-winning organization with a culture centered around our core values: courage, learning, integrity, collaboration, and innovation.
Requirements
  • MSc in Biomechanics or a related discipline.
  • Extensive experience in applying biomechanical principles.
  • Proven experience in leading gait lab activities.
  • Experience executing clinical trials and clinical evaluations for medical devices.
  • Experience with MDD/MDR regulations.
  • Experience applying ISO-13485 and ISO-14971 standards.
  • Breadth of understanding across other engineering domains, including electrical, mechanical, and software engineering.
  • A naturally inquisitive and problem-solving mindset.
  • A positive, team-oriented attitude with a 'can-do' approach.


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