Head of Research Development

3 months ago

Crawley West Sussex, United Kingdom Welland Medical Ltd Full time

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. Welland Medical is a part of Clinimed Holdings Limited, a prominent figure in the Healthcare and Medical Equipment sector. Clinimed Holdings Limited comprises a group of companies established in 1982 through the acquisition and formation of various entities within the group.

We believe that investing in our people is critical to our success and we're committed to helping our employees develop their skills, advance their careers, and achieve their professional goals.

We're proud of our company culture, which is built on a foundation of collaboration, teamwork, and open communication. As the leader of our established 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. You will be actively engaged in the New Product Development process, guiding and shaping new product strategies, maintaining the product roadmap, and overseeing design and technical specifications. Your contributions will be pivotal in advancing Welland’s New Product Development process, ultimately transforming patient care through groundbreaking solutions.

As the Head of R&D, you will be a key member of the leadership team, driving the strategic direction of new product development.

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.
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.
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.
Collaborate with QARA, Production, and Engineering teams to ensure seamless transitions throughout the NPD pipeline.
Evaluate and mitigate risks using DFMEAs or other appropriate methodologies.
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).
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.

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.

Design experience within the medical device field.
Experience with injection moulding.
Experience working within a manufacturing/industrial environment.
Strategic decision-making ability, capable of developing and executing strategies to enhance product design and manufacturing processes, aligning with company goals, and defining team training requirements.
Proficiency in 3D CAD and associated analysis tools, with strong skills in SolidWorks or similar software.
Excellent problem-solving abilities, adept at root cause analysis, identifying issues, and generating design solutions in compliance with specifications.
High computer literacy, coupled with exceptional planning, organizational, and time management skills.
Experience in medical device design is advantageous, but all product design experience is valued.
Solid technical knowledge of manufacturing processes, quality control, supply chain management, and inventory control.
Strong analytical skills, capable of interpreting complex data and making informed decisions, including strategic planning and budgeting.
Commitment to continuous improvement (CI) in processes and systems to enhance efficiency, reduce waste, and improve quality.
Knowledgeable about safety and regulatory compliance (QMS), ensuring adherence to all relevant laws and standards.

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