Product Design Engineer

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
As a Product Design Engineer, your main responsibilities and duties will include:

• 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.
• Work cohesively within a multi-disciplinary project team, to achieve key milestones through a staged product development process utilising 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.

Additional Responsibilities Will Include

• Continuously improve and maintain the existing range of Welland Medical products currently in the market.
• Support and enhance technical analyses of the marketplace and competitive landscape; including creating data to drive key Welland Medical strategies and activities.
• Compiling necessary documentation for new products and/or product improvements to support submission to notified bodies; ensuring compliance to applicable regulations and standards.
• Review and, where applicable, devise technical methodologies for ostomy-relevant products throughout the product lifecycle (including within Operations).
• Supporting QA/RA in technical investigations of customer complaints and in compilation of technical sections of regulatory submissions.
• Ensuring novel inventions are suitably protected for the Business via creation of patents.

Other Duties

• A degree of flexibility is needed, 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.

For more information about the role or to apply don't hesitate to get in touch with us