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.