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.
- 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
- 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
- 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
- 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
- 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.