Main Purpose of Role

• To provide effective senior leadership and technical support during the product design and process development of the Company's structural heart product pipeline.
• To support quality and regulatory compliance in accordance with ISO 13485 in all aspects of work undertaken.

Main Responsibilities:

• Product, component and tooling design utilising mathematical processes and CAD in a transparent, methodical and well-documented manner in line with design inputs
• Excellent hands-on technical manufacturing ability with a focus on prototype product, components and process equipment
• Responsible for planning and execution of DoE trials to drive progress
• Provide effective senior leadership within RUA's Structural Heart product developments
• Ownership of project milestones
• Develop and execute mechanical / physical bench performance testing of prototypes/ components, in line with appropriate standards when necessary
• Delegate for the Director when required
• Identify, assess and liaise with technical contractors regarding specifications, designs , prototyping, testing and general product & process development needs
• Implement design for manufacture principles into product and process design activities
• Devise methods for effective data capture and trending to ensure effective direction and progress
• Proactive multi-departmental collaboration
• Support design or process transfer when appropriate
• Generation of fit for purpose quality documentation to support design control and the QMS
• Perform other duties as required to support both personal and team professional development

Additional Responsibilities:

• Ensure conduct is in accordance with RUA's five values - innovation, agility, integrity, quality and collaboration.
• Participation in the management of company Health & Safety initiatives including e.g., risk assessments, COSHH, job hazard analysis, PPE management.

Knowledge and experience required

Essential

• Experienced in design & physical product development preferably in the medical device industry
• Experienced in manufacturing process development and knowledgeable in DfM
• Proficient in CAD & mathematical theory
• Experienced in methodical investigation of complex systems consisting of numerous variables using techniques such as DoE
• Experienced in working within ISO 13485 environments, including solid understanding of design control, verification & validation
• Excellent team player / collaborator
• Excellent communicator across all media
• Excellent organisational skills
• First class problem solving abilities and attention to detail

Desirable

• Knowledge and experience in Heart Valve design and development
• Knowledge and experience in medical textile design & processes
• Knowledgeable of FEA theory
• Lean/six sigma expertise
• Project Management
• Risk Management and FMEA experience

Qualifications

• Degree in an engineering discipline or relevant on the job experience

Escape Recruitment are appointed recruiters for RUA Medical and third party, direct or speculative applications / CVs will be forwarded to Escape for consideration.