Product Design Engineer
4 days ago
Crawley
About Welland Medical Ltd: Welland Medical brings to market the best and most innovative products that enhance the lives of people living with a stoma across the world. Investing in the most talented people, collaborating to create world-class, ground-breaking products and services devoted to improving peoples’ lives. We are passionate about making a difference in the world. Welland Medical is a part of Clinimed Holdings Limited, a prominent figure in the Healthcare and Medical Equipment sector. Clinimed Holdings Limited comprises a group of companies established in 1982 through the acquisition and formation of various entities within the group. Job Summary: Working closely with all functions within R&D, the successful applicant will lead the development of new and existing products, from initial concept through to commercial launch. This role is key in delivering innovative, cost-effective, and regulatory-compliant solutions that meet the needs of both patients and healthcare providers. Our R&D team, comprising Designers, Engineers, and Material Scientists, is driving technological advancement in the field. As part of this team, you’ll play a vital role in Welland’s New Product Development process, helping to transform patient care through innovation. Main Duties & Responsibilities: • Leading and contributing to the design and development of new products, ensuring alignment with regulatory requirements (ISO 13485, MDR, etc.) and internal design control processes., • Acting as a Subject Matter Expert (SME) by providing design and technical insights to project teams and supporting strategic business decisions., • Working collaboratively within a cross-functional project team to deliver products through a staged development process, ensuring delivery within agreed timelines and budgets while managing risk., • Proactively identifying, assessing, and mitigating design and project risks in accordance with ISO 14971., • Evaluating intellectual property opportunities and risks as part of product innovation and development., • Supporting and contributing to specific workstreams within development projects to ensure products meet clinical, user, and operational requirements., • Creating and reviewing comprehensive technical documentation and reports for both internal and external distribution., • Championing continuous improvement within the R&D function by identifying skill gaps, enhancing processes, and seeking opportunities for personal and team development., • Planning, executing, and documenting product testing and trials, including the creation of new test methods where existing standards are not sufficient., • Maintaining and calibrating assigned test and pilot equipment, including developing associated work instructions and risk assessments., • Producing conceptual prototypes, CAD models (including complex assemblies), and detailed technical drawings in line with BS 8888 standards., • Providing mentorship and support to junior R&D team members, contributing to a collaborative and knowledge-sharing environment. This role requires engagement across a wide range of internal stakeholders, including colleagues in R&D, Regulatory Affairs, Sales & Marketing, and Operations. You will also liaise with external partners such as suppliers, regulatory bodies, technical collaborators, and affiliated companies within the wider group. Other Duties: • Supporting the ongoing improvement and maintenance of Welland Medical’s existing product portfolio., • Contributing to technical market and competitor analysis to support strategic planning and innovation activities., • Preparing documentation to support regulatory submissions for new products or modifications, ensuring compliance with all applicable standards and regulations., • Reviewing and developing technical methodologies relevant to ostomy products across the full product lifecycle, including manufacturing., • Supporting the Quality Assurance and Regulatory Affairs teams with technical investigations related to customer complaints and regulatory submissions., • Ensuring innovative technologies and designs are protected by supporting the creation and filing of patent applications. Personal Specifications: Essential: • Degree in Product Design, Engineering, or a related discipline., • Minimum 5 years’ experience in R&D or Engineering within the medical device or a similarly regulated industry., • Proven ability to translate user needs into commercially viable products., • Strong knowledge of design controls, testing, data analysis, and risk management (e.g. ISO 13485, ISO 14971)., • Experience with CAD software, technical drawing standards (e.g. BS8888), and document control systems., • Demonstrated project management skills with the ability to plan, prioritise, and deliver to deadlines., • Excellent problem-solving, root cause analysis, and technical reporting skills., • Strong communication and interpersonal abilities; able to work both independently and in cross-functional teams., • High level of computer literacy and a human-centred design mindset., • Proactive, self-motivated, and able to work with minimal supervision. Desirable: • Postgraduate qualification in a design-related field., • 8+ years’ experience in medical device development, including project leadership., • Knowledge of applicable standards (ISO 9001, ISO 13485, ISO 10993) and experience with product/process validation., • Familiarity with statistical techniques and Design of Experiments (DoE)., • Cross-functional experience with QA/RA, Marketing, Clinical, and Operations teams., • Practical prototyping skills and hands-on development experience.