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Senior Engineer, Product Design Engineering
2 months ago
Welland Medical is the part of Clinimed Holdings Limited group, a leading name in Healthcare and Medical Equipment industry. Clinimed Holdings Limited is a group of companies founded in 1982 following the acquisition and formation of number of additional companies within the group.
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. Our reputation is based on a tradition of improvement, ethical leadership, and total commitment to quality and safety.
We're proud of our company culture, which is built on a foundation of collaboration, teamwork, and open communication. Contributory Pension Scheme
Medical Cash Back Plan
Life Assurance (4 x Annual Gross)
Cycle to Work Scheme
Employee Referral Scheme
Discounts on Selected Products and Services
Employee Assistance Programme – Health and Wellbeing
Annual Leaves - 25 Days Per Year Rising to 27 Days After 5 Years Service In Addition to Bank Holidays and An Extra Company Day
As a Senior Design Engineer, you will lead the development of both new and existing products from concept to launch, ensuring that innovative, cost-effective, and compliant solutions meet the needs of patients and customers.
Contribute to the development of Ostomy-centric medical devices from initial concept through to transfer to Operations, adhering to Welland Medical's Innovation strategy, QMS procedures, and NPD process.
Provide subject matter expertise and technical input for design and strategic business decisions.
Execute project activities within a Design Controls framework in compliance with ISO 13485, MDR, and other relevant regulations and quality systems.
Lead multi-disciplinary project teams, using project management principles to achieve key milestones and deliver projects on time and within budget. Manage risks and keep stakeholders informed throughout the process.
Identify, manage, and mitigate design and project risks in accordance with ISO 14971.
Assess intellectual property opportunities and risks.
Contribute to various work-streams within product development projects, ensuring that products meet customer expectations and operational needs.
Create and review technical reports and design documentation for internal distribution and, when applicable, external stakeholders.
Foster continuous improvement by proactively seeking development opportunities to enhance the R&D team's skills and expertise.
Conduct testing and trials in a timely manner, including developing new test methods as needed.
Maintain and calibrate assigned test and pilot equipment and create and review work instructions and risk assessments.
Prepare conceptual prototypes, visualizations, complex CAD assemblies, and detailed technical drawings in accordance with BS8888.
This role involves interacting with a diverse range of contacts at various levels within the organization, including R&D, Regulatory Affairs, Sales & Marketing, and Operations teams. Externally, you will engage with partner Holdings companies, suppliers, key technical partners, and regulatory bodies.
Continuously improve and maintain the existing range of Welland Medical products.
Enhance technical analysis of the marketplace and competitive landscape to inform Welland Medical’s strategies and activities.
Support QA/RA in technical investigations of customer complaints and in preparing technical sections of regulatory submissions.
Bachelor’s Degree in Product Design, Engineering, or a related discipline.
A minimum of 3 years’ experience in a R&D or engineering role within the medical devices or a similarly regulated industry.
Experience in a medical device company, ideally as a Lead Product Developer.
Proven ability to bridge cross-functional teams, including Technical, Marketing/Sales, Quality, Regulatory, and external customers/suppliers.
Demonstrated expertise in understanding user requirements, developing ideas, transforming them into concepts, and refining them into commercial products.
Strong knowledge of test development and execution, including data collection, analysis, and interpretation.
Project management experience.
Excellent problem-solving skills with the ability to analyze issues, generate design solutions, and perform root cause analysis in compliance with design specifications.
Proficiency in CAD software and technical drawing management systems.
High level of computer literacy.
Strong planning, organizational, and time management skills.
Highly motivated, proactive, and capable of working with minimal supervision.
