About Us:

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.

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. Our employees are passionate, driven, and committed to delivering the best possible results for our customers.

About Job:

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. Additionally, you will support material and product verification and validation efforts.

Our R&D team, composed of Engineers, Designers, and Technical Experts, is at the forefront of innovation in the ostomy device industry. 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.

Main Duties & 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:

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.

Experience:

Essential:

• 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.

Desirable:

• Design experience within the medical device field.
• Experience with injection moulding.
• Experience working within a manufacturing/industrial environment.
• Strong understanding of manufacturing principles for high-volume consumable products.

Skills:

• Strong Design Engineering/Product Design skills, with a passion for design, a commitment to learning, and a willingness to foster collaboration.
• Extensive leadership, management, and interpersonal skills, with experience at a senior level in a manufacturing environment, demonstrating the ability to lead, motivate, and inspire teams.
• 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.
• Highly motivated and proactive, capable of working independently as part of the leadership team.
• A drive for exploration, constantly seeking new methods, processes, and technologies to innovate and translate ideas into new product offerings.
• Strong understanding of manufacturing principles for high-volume consumable products, with experience in R&D Engineering and knowledge of FMEA and DFMA.
• Experience in medical device design is advantageous, but all product design experience is valued.
• Experience with design and manufacturing standards such as ISO 9001, MDR, ISO 13485, ISO 10993 (biocompatibility), and FDA Design Control is desirable.
• 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.
• Effective communication skills, able to convey complex information to both technical and non-technical audiences.
• Commitment to continuous improvement (CI) in processes and systems to enhance efficiency, reduce waste, and improve quality.
• Strong people management skills, with experience in developing R&D professionals and fostering a culture of continuous learning.
• Knowledgeable about safety and regulatory compliance (QMS), ensuring adherence to all relevant laws and standards.