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.