Head of Research and Development

1 week ago

Crawley, West Sussex, United Kingdom Welland Medical Ltd Full time

About Us:

Welland Medical Ltd is a leading company in the healthcare industry, dedicated to developing innovative products that improve the lives of people with a stoma. Our team is passionate about creating cutting-edge solutions that make a difference in the world.

We are part of Clinimed Holdings Limited, a prominent figure in the Healthcare and Medical Equipment sector. Our company culture is built on collaboration, teamwork, and open communication, and we are committed to helping our employees develop their skills and advance their careers.

About the Job:

We are seeking a highly skilled and experienced Head of Research and Development to lead our R&D team. As the leader of our creative team, you will collaborate closely with all members of the R&D department and the broader organization to develop cutting-edge medical devices for Ostomy Care.

Key Responsibilities:

  • Lead and mentor the Research and Development team/s focused on the development of new medical devices, in the Ostomy field, providing guidance, training, and support to foster a high-performing, innovative environment.
  • Manage a multidisciplinary team comprising Product, Mechanical, and Design Engineers, Research Scientists, and Senior Materials Research Engineers, ranging from entry-level to senior level.
  • Oversee and continuously improve Welland's development process within the New Product Development (NPD) framework, ensuring it remains current and adaptable to regulatory changes and departmental advancements.
  • Ensure the R&D team possesses the necessary skills to conceptualize, develop, and bring to life innovative solutions and products.
  • Oversee all IP management processes for new and existing designs, including assessing potential IP infringements, managing patent renewals, and submitting new applications.
  • Project manage the entire device development process through phase gates and product lifecycle, 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, including biological evaluation reports, traceability matrices, DFMEAs, and raw materials and packaging specifications, ensuring accuracy and completeness.
  • Drive new product, material, and process development, including initial characterization, verification, and validation in line with company procedures.
  • Manage and maintain Welland's product roadmap, ensuring alignment with strategic goals.
  • Develop and monitor project cost and time plans, implementing mitigation strategies when necessary.
  • Provide technical expertise and guidance in business decision-making, especially within your specialty area.
  • Act as the technical liaison with customers, and participate in Sales & Marketing and R&D meetings, offering technical solutions and product support.
  • 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.
  • Collaborate with QARA, Production, and Engineering teams to ensure seamless transitions throughout the NPD pipeline.
  • Build and maintain relationships with external design houses, technical consultancies, and specialists to advance Welland's strategic initiatives.
  • Evaluate and mitigate risks using DFMEAs or other appropriate methodologies.
  • Manage Bill of Materials (BoM) using Welland's ERP system and define costs for new products.
  • Oversee the recruitment, management, and development of the R&D teams, ensuring performance management and personal development reviews focus on achieving KPIs and enhancing competencies.
  • Manage departmental budgets, adhering to approved financial plans and schedules, and contribute to the annual strategic planning process.
  • Uphold Welland's commitment to high-quality product standards and reliability benchmarks.
  • Ensure compliance with the Welland Medical Quality System, standards, and regulatory requirements, including adherence to ISO13485 and the Medical Device Regulation (MDR).
  • Understand and apply principles of Lean Manufacturing and Continuous Improvement (CI).

About You:

We are looking for a highly skilled and experienced professional with a strong background in R&D management, product development, and innovation. You should have a degree in a relevant field, such as science or technology, and a strong understanding of manufacturing operations.

Key Qualifications:

  • A degree in a relevant field such as science or technology is desirable, with a strong understanding of manufacturing operations.
  • 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, delivered on time, within budget, and to the required standards.

Key Experience:

  • 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, and a deep understanding of the product development process.
  • 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.

What We Offer:

We offer a competitive salary and benefits package, as well as opportunities for professional growth and development. If you are a motivated and experienced professional looking for a new challenge, please submit your application.

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