Research and Development Director

3 days ago


Crawley, West Sussex, United Kingdom Welland Medical Ltd Full time
About the Role

We are seeking an exceptional Research and Development Manager to lead our team in developing cutting-edge medical devices for Ostomy Care. As the Head of R&D, you will be responsible for driving the strategic direction of new product development, collaborating with cross-functional teams, and overseeing the development process from concept to clinical trial readiness.

Key Responsibilities
  • Lead and mentor a multidisciplinary team of engineers, researchers, and scientists to develop innovative medical devices.
  • Oversee the development process, ensuring compliance with regulatory requirements, including ISO 13485 and the Medical Device Regulation (MDR).
  • Project manage the entire device development process, aligning with Welland's strategic plans and product roadmap.
  • Contribute to the development of new devices, from initial concept to clinical trial readiness, in accordance with Welland's development strategy, quality system, and process.
  • Review and oversee technical reports and design documentation, ensuring accuracy and completeness.
  • Drive new product, material, and process development, including initial characterization, verification, and validation in line with company procedures.
  • Develop and monitor project cost and time plans, implementing mitigation strategies when necessary.
  • Support distributor co-creation and complex complaint resolution, working closely with Quality Assurance and Regulatory Affairs (QARA) in technical investigations and regulatory submissions.
  • Serve as the technical authority for Welland Medical's product portfolio, both internally and externally.
Requirements
  • BEng or BSc in Product/Industrial Design, Mechanical Engineering, Biomedical Engineering, or equivalent academic/work experience.
  • Project Management qualification (e.g., PRINCE2 or equivalent) to ensure effective planning, execution, and management of projects.
  • Hands-on leadership, motivation, and development of an R&D team.
  • Strong technical and innovation background, with experience delivering projects from concept through to manufacturing.
  • Experience working as part of a senior management team, contributing to strategy development and execution.
  • Proven track record in budgetary control, ensuring compliance with agreed financial targets.
  • Project management experience, including planning, execution, and management within an R&D and manufacturing environment.
  • Experience in patent development, management, and application.
  • Financial acumen, with the ability to manage costs, drive revenue growth, and optimize profits.
  • Management of safety and regulatory compliance (GMP) in a manufacturing environment.
  • Experience working to medical design standards within the medical device industry, including MDR, ISO 13485, and FDA Design Control.
  • Design experience within the medical device field.
  • Experience with injection moulding.
  • Experience working within a manufacturing/industrial environment.
What We Offer

As a Research and Development Manager at Welland Medical Ltd, you will have the opportunity to work on cutting-edge medical devices, collaborate with a talented team, and contribute to the development of innovative products that enhance the lives of people living with a stoma. We offer a competitive salary, comprehensive benefits package, and opportunities for professional growth and development.



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