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. Our reputation is based on a tradition of improvement, ethical leadership, and total commitment to quality and safety.
Welland Medical, established in 1988 is part of the CliniMed Group, and has over 250 colleagues committed to enhancing people’s lives.
Main Duties And Responsibilities
* Conduct primary and secondary design research, ensuring user needs, intended use, and design inputs are clearly captured, documented, and traceable in line with ISO 13485.
* Support the development of design inputs and user requirements, aligned with clinical needs, regulatory expectations, and risk management processes.
* Contribute to concept generation and structured ideation sessions, ensuring outputs are documented and linked to design inputs.
* Evaluate and select concepts using defined criteria (e.g., feasibility, risk, usability, manufacturability), maintaining clear design records and justification.
* Plan and conduct usability engineering activities in line with human factors best practices.
* Develop and document prototypes (from proof‑of‑concept to functional models) to support verification and validation.
* Assist Design Engineers with day‑to‑day project tasks.
* Apply structured problem‑solving techniques, considering risk, safety, and regulatory impact, with appropriate documentation.
* Communicate effectively with internal teams (Quality, Regulatory, Manufacturing) and external stakeholders (suppliers, subcontractors), ensuring traceability of decisions.
* Produce detailed 3D CAD models using SolidWorks.
* Generate high‑quality renders using KeyShot to support design reviews and stakeholder engagement.
* Support the full product lifecycle, including design, development, verification, validation, and transfer to manufacture in compliance with ISO 13485.
* Support verification and validation testing, including protocol development, execution, and reporting.
* Assist with regulatory documentation and audit preparation.
* Participate in design reviews, ensuring outputs meet inputs and that risks and decisions are properly recorded.
* Support user evaluations, presentations, and focus groups, feeding insights back into the design process.
* Develop prototypes to a professional standard, aligned with design requirements and documentation.
Other Duties
Adherence to the Company’s Health and Safety policy at all times and operate and promote the development of quality standards and procedures, taking ownership of tasks and seeking new improved ways of doing things.
A degree of flexibility is required, and the job holder may be required to perform work not specifically referred to above and which will be appropriate to the level of the role. All duties must be carried out in compliance with company Quality System, Health and Safety Policies and regulations set out in the Medical Device Directive.
Quality is an integral part of the company’s mission to deliver innovative products and service. All members of staff are responsible for operating and promoting the development of quality standards and procedures.
Continuous Improvement – The company is committed to a culture of continuous improvement. All members of staff are expected to take ownership of tasks and seek new and improved ways of doing things.
For more information about the role or to apply with your CV, cover letter and portfolio, don’t hesitate to get in touch with us at recruitment@wellandmedical.com.
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