Design Engineer

Location: Hybrid / Bradford BD12, UK
Job type: Permanent / Full-time
Sector and subsector: Science | Research & Development
Annual Salary range: from £40,000.00 to £45,000.00

At Winncare, we are dedicated to enhancing the quality of life for individuals in need of mobility and care solutions. With over four decades of expertise, we specialise in developing and providing innovative products and services that support the healthcare industry, including lifting and transfer equipment, medical beds, and a wide range of care solutions.

Our commitment to excellence is driven by a passion for improving the everyday lives of patients and caregivers alike, ensuring safety, comfort, and dignity for those we serve. As a trusted partner in healthcare, Winncare continues to lead with innovation, compassion, and a relentless pursuit of quality.

This is an exciting time for Winncare as we experience organisational growth and new opportunities to join our highly skilled, professional, and committed team in a great working environment.

Due to our growth and to support the continued delivery of excellent service to our customers and the sector, we are now seeking to appoint a qualified, experienced, and highly capable Design Engineer.

Reporting to the Head of Research & Development (R&D), the Design Engineer will be required to present ideas and solutions by applying a highly advanced level of specialist, detailed technical expertise to problem solving.

The successful candidate will be responsible for the design and development of innovative, market leading concepts and lead on assigned projects. Duties will also include the planning and leading allocated projects, contributing to on time and budget delivery, adapting to changing circumstances promptly.

The Design Engineer will create and maintain a Design History File (DHF) and other regulatory driven documentation requirements and deliver project credibility through structured development via prototyping, testing, verification, and validation.

• Use CAD to produce models, assemblies, engineering drawings (including dimensioning & tolerancing), and FEA.
• Controlled implementation of documented changes to improve product quality & manufacturing efficiencies. Project management and lead on allocated R&D projects including project planning, scheduling, budgeting, and management of the project team to fulfil project goals.
• Where applicable, comply with Research, Development & Design Control procedure and maintain required project documentation detailing analysis of processes and testing.
• Lead on device technical files conducting remediation work where required to ensure MRD CE Marking compliance.
• Support notified body technical questions as a result of audits or technical file submissions.
• Develop & implement product & process testing, verification, and validation protocols; identify & implement testing, verification, and validation of designs. This will include report writing.
• Comply with policies, legal and regulatory obligations. Ensures that the design control process is adhered to according to EN ISO 13485.

• A degree in an engineering subject;
  Mechanical design & engineering, biological engineering, or electrical engineering would be advantageous.
• Minimum three years within the medical devices industry.
• Experience in CAD modelling & assemblies with ability to undertake FEA and produce high quality manufacturable engineering drawings & robust designs.
• Experience working within a Quality Management System, preferably EN ISO 13485 and be experienced in creation of technical files to support product families/groups as well as design risk management to 14971.
• Strong understanding of EU MDR, as well as international standards & regulations (ISO 13485:2016 & FDA 21 CFR Part 820 etc.) would be very advantageous.
• Excellent project management, communication and organisational skills required for project progression & overcoming obstacles, capable of working independently but a real team player who performs and collaborates well within a team to deliver a successful project.
• Hold a full UK driving licence.

Due to the geographical locations of the Company and client base, it is essential applicants hold a full UK driving licence.