System Engineering Manager - Clinical Trials & Validation

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.