About Us:
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. 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.
We're proud of our company culture, which is built on a foundation of collaboration, teamwork, and open communication. Our employees are passionate, driven, and committed to delivering the best possible results for our clients.
If you have passion for learning and want to build a career with a company that values its employees and is dedicated to making a positive impact in the world, we encourage you to apply.
Benefits:
- Contributory Pension Scheme
- Medical Cash Back Plan
- Life Assurance (4 x Annual Gross)
- Cycle to Work Scheme
- Employee Referral Scheme
- Free Yearly Flu Vaccination
- 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
About Job:
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.
You’ll be at the forefront of technology in the ostomy device industry, collaborating with a team of engineers, designers, and technical experts. Your work will be crucial to Welland’s New Product Development process, driving innovation and enhancing patient care.
Main Duties & Responsibilities:
- 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.
- Mentor junior members of the R&D team.
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.
Additional responsibilities include:
- 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.
- Compile documentation for new products or improvements to support submissions to notified bodies, ensuring compliance with regulations and standards.
- Develop technical methodologies for ostomy-related products throughout their lifecycle, including in Operations.
- Support QA/RA in technical investigations of customer complaints and in preparing technical sections of regulatory submissions.
- Protect novel inventions through the creation of patents.
About You:
An ideal candidate for this position will have the following experience, skills, and attributes. Please note that these competencies are not ranked in order of priority. Following criteria will be used in selecting a candidate.
- 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.
- Familiarity with relevant regulations such as ISO 9001, ISO 13485, and ISO 10993 (Biocompatibility).
- Experience with product and process validation activities and regulations.
- 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.
- Driven to explore new methods and technologies, with a passion for investigating innovative processes and translating them into new product offerings.