OverviewWelland Medical Ltd is part of Clinimed Holdings Limited, a group established in 1982 in the Healthcare and Medical Equipment sector. Welland Medical brings to market innovative products that enhance the lives of people living with a stoma. We invest in talented people to develop world-class, ground-breaking products and services to improve people’s lives.Job title and role details are described below. This role focuses on leading the development of new and existing products from concept through to commercial launch, delivering innovative, cost-effective, and regulatory-compliant solutions that meet the needs of patients and healthcare providers.Job SummaryWorking 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. The R&D team includes Designers, Engineers, and Material Scientists, and you will play a vital role in Welland’s New Product Development process to transform patient care through innovation.Main Duties & ResponsibilitiesLeading 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.Other DutiesSupporting 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 SpecificationsDegree 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.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. #J-18808-Ljbffr