Senior Design Engineer

Based in Crawley and working closely with the Head of R&D, this is an exciting opportunity for the successful applicant to join a multidisciplinary R&D team. Specifically, this role will involve leading the development of new and/or existing products from concept through to launch – ensuring innovative, cost-effective and compliant solutions that meet patient and customer needs are brought to the market. Our R&D team of Engineers, Designers and Technical experts are in the forefront of technology in the ostomy device industry. You will be making a vital contribution to Welland’s New Product Development process and transforming patient care through innovation.

Main Duties and Responsibilities

• Contribute to the development of new Ostomy-centric medical devices from early-stage product concepts through to transfer to Operations, in line with the Welland Medical Innovation strategy, QMS procedures and NPD process
• Provide SME (subject matter expert) design and technical knowledge input to relevant activities and strategic business decision making.
• Carry out project activities within a Design Controls framework in accordance with ISO 13485, the MDR and other key Regulations, and relevant Quality systems.
• Manage multi-disciplinary project teams, to achieve key milestones through a staged product development process utilizing project management principles.Deliver assigned projects in a timely manner, within budget, whilst managing risk and ensuring key stakeholders are kept informed.
• Consider, manage and mitigate all design and project risk, in accordance with ISO 14971.
• Evaluation of IP opportunity and risk.
• Contribute to allocated work-streams within product development projects, meeting project targets and ensuring products meet customer expectations and operational needs.
• Create and review technical reports and/or design documentation for distribution both within Welland Medical and – where applicable – externally.
• Adopt a continuous improvement approach, proactively seeking development opportunities to ensure the R&D team has the skills and expertise to deliver business needs.
• Execute testing and trials in a timely manner, including the development of new test methods where gaps are identified.
• Ensure continued maintenance and calibration of assigned test and pilot equipment. Create and review work instructions plus risk assessments.
• Preparation of conceptual prototypes/visualisations, complex CAD assemblies and detailed technical drawings in accordance with BS8888
• Provide mentorship for more junior members of the R&D team

The nature of this role will require the individual to deal with a wide range of contacts at different levels of seniority within the organization, ranging from within R&D, Regulatory Affairs, Sales & Marketing through to the Operations teams.
In addition, the individual will deal with contacts external to the organization – ranging from (but not exclusively limited to) other partner Holdings companies, suppliers, key technical partners and Regulatory bodies.

For more information about this role, please contact our Recruitment team.