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System Engineering Manager

3 months ago

Basingstoke, United Kingdom Blatchford Full time

Blatchford is an innovative, multi-award-winning, global, manufacturer of some of the world’s most advanced prosthetic technology, bespoke seating solutions and orthotic devices.


Our evidence-based approach and commitment to continuously challenge possibilities ensures our mobility solutions prioritise the wellbeing and long-term health of our users.


Through innovation, science, technology, and maintaining a clear focus on people, we make mobility possible.


Due to the continued growth and development of our dynamic, multi-disciplinary R&D team, we have an exciting opportunity for a System Engineering Manager – Clinical Trials & Validation, at our Head Office in Basingstoke.


The role


As System Engineering Manager – Clinical Trials & Validation, you will be responsible for trials and studies of company products, including identification of KPIs and creation of reports. You will support the development of V&V and Post market Surveillance activities.


Key duties.


  • Leading the team to define and successfully execute Clinical Evaluations and studies for the products.
  • Defining the roadmap for the R&D clinical team and drive its implementation to achieve superior clinical outcomes.
  • Actively contributing to the quality improvement process.
  • Reviewing and approving technical documentation, as defined in QMS, contributing to Design Reviews for active projects and ensuring effective technical leadership.
  • Effectively communicating status on a regular basis to management and interacting with peers to optimise activities.
  • Managing allocated budget.


What can we offer you?


As System Engineering Manager – Clinical Trials & Validation, you will receive the following:


Benefits


  • Highly completive salary
  • Flexible, hybrid working.
  • 25 days holiday (rising with service)
  • Option to purchase additional annual leave.
  • Pension
  • Death in service
  • Discounted shopping and leisure activities
  • Health cash plan
  • Cycle to work scheme.
  • Opportunity to be part of an award-winning organisation with a culture that centres around our core values; courage, learning, integrity, collaboration, and innovation


What are we looking for?

To be considered for the System Engineering Manager – Clinical Trials & Validation opportunity, you will have the following:


Essential skills


  • MSc in Biomechanics or similar discipline.
  • Extensive experience of applying biomechanical principles.
  • Proven experience in leading gait lab.
  • Experience executing clinical trials and clinical evaluations for medical devices.
  • Experience with MDD/MDR.
  • Experience applying ISO-13485 and ISO-14971.
  • Breadth of understanding across other engineering domains, i.e. electrical, mechanical, software.
  • A naturally inquisitive, problem solver.
  • A positive, team player with a “can do” attitude.