Principal R&D Engineer
ConvaTec Inc, Shotton, Sir y Fflint - Flintshire
Principal R&D Engineer
Salary not available. View on company website.
ConvaTec Inc, Shotton, Sir y Fflint - Flintshire
- Full time
- Permanent
- Remote working
Posted 2 weeks ago, 2 Oct | Get your application in now before you miss out!
Closing date: Closing date not specified
Job ref: b278de2a7bef4a8f9a1c042393d185c6
Location ref: Shotton, Sir y Fflint - Flintshire
Full Job Description
We're looking for a Principal R&D Engineer to join our Infusion Care R&D team and play a key role in shaping the next generation of products and technologies. This is a highly visible technical leadership position where you'll lead customer projects, new product development initiatives, and change control activities across a global portfolio of medical devices. As we expand our focus beyond product remediation and into exciting new development opportunities, you'll have the chance to influence product strategy, challenge existing ways of working, drive continuous improvement, and collaborate with cross-functional teams across R&D, Operations, Quality, Regulatory, Commercial, and Manufacturing. This role is ideal for someone who combines strong technical expertise with sound judgement, a proactive mindset, and the confidence to lead projects, make decisions, and influence stakeholders at all levels.,
- Provide technical leadership for new product development, customer projects, and product lifecycle management activities.
- Lead design and development activities in accordance with Design Control and regulatory requirements.
- Drive change control projects across existing products, components, materials, packaging, labelling, and manufacturing processes.
- Own and maintain Design History Files (DHFs), risk management documentation, and Design Control records.
- Lead technical investigations, root cause analysis activities, CAPAs, and non-conformance assessments.
- Make data-driven recommendations and provide clear technical direction for complex engineering challenges.
- Work closely with cross-functional stakeholders including Operations, Commercial, Quality, Regulatory Affairs, Manufacturing, and external partners.
- Influence project teams by challenging assumptions, identifying opportunities for improvement, and driving effective solutions.
- Support the development of more efficient and effective R&D processes while promoting best practices across the organisation.
- Apply Design for Manufacturing (DFM) and Design for Assembly (DFA) principles to ensure robust, scalable product designs.
- Mentor colleagues and provide technical guidance that helps the wider team achieve shared goals.
- Stay at the forefront of industry developments through technical research, publications, patents, supplier engagement, and professional networking.
Essential - Significant experience in medical devices, drug delivery systems, pharmaceutical products, or another highly regulated life sciences environment.
- Strong expertise in Design Control and management of Design History Files (DHFs).
- Proven experience leading product development and change control projects.
- Demonstrated ability to make decisions, assess risk, and drive projects forward with minimal supervision.
- Experience influencing cross-functional stakeholders and leading technical discussions.
- Excellent problem-solving and root cause investigation skills.
- Ability to manage multiple concurrent projects and priorities.
- Strong written and verbal communication skills in English. Desirable
- Experience using CAD software, particularly SolidWorks.
- Knowledge of ISO 13485, ISO 14971, and FDA 21 CFR Part 820 requirements.
- Experience with RCA methodologies including 5 Whys, Ishikawa Diagrams, and FMEA.
- Project management experience.
- Experience improving engineering or development processes through simplification, efficiency, or continuous improvement initiatives., Bachelor's degree or higher in Mechanical Engineering, Systems Engineering, Design Engineering, Medical Engineering, or another relevant STEM discipline.
Convatec has announced a major milestone in our R&D journey and commitment to our vision of pioneering trusted medical solutions to improve the lives we touch. We have unveiled plans to relocate the majority of our UK-based research and development (R&D) activities from Deeside to Manchester from late 2027/early 2028, alongside a significant expansion of our facilities in Boston. The new, planned Manchester facility has the potential to be a major R&D hub in our global network which will initially function as the company's global testing laboratories, with cutting-edge analytical R&D capabilities including quality control and materials, regulatory functions, and health innovation, positioning Convatec at the forefront of medical technology development. Our new state-of-the-art facilities will also strengthen our collaboration with Manchester's vibrant life sciences ecosystem, which includes leading universities, hospitals, and research institutions., At Convatec, we're pioneering trusted medical solutions to improve the lives we touch. If you're ready to make a real impact, apply today and help us bring our Forever Caring promise to life. - Remote working with occasional requirement to work onsite at Deeside's Global Development Centre.
- Global Development Centre (GDC) will move to Manchester once Convatec completes its transition to the new R&D Hub in late 2027/early 2028. Special Factors
- Convatec is a multi-national company, therefore a degree of flexibility in the working day may be required when working with non-UK based colleagues.