Head of Research and Development

Welland Medical, one of the leading ostomy brands in the UK and worldwide, specialise in the design, development and manufacture of innovative stoma care appliances and accessories. Welland Medical is renowned for manufacturing ground breaking solutions that enhance people’s lives, every day. Situated in a purpose-built state of the art research, development and manufacturing facility, Welland Medical has a growing workforce of over 240 skilled colleagues. Part of the privately owned CliniMed Group, which established in 1982, provides specialist products and services to the healthcare market.

Overall Purpose of the Role:

Your unique talents and perspective can make a vital contribution to innovative products that improve the lives of Ostomists everywhere. A career opportunity within Welland Medical may provide you with
an ideal setting to build your experience; express your passion and make a difference. Leading an existing creative team, the successful candidate will be working closely with all members of R&D and the wider organisation supporting information to develop Medical Devices for Ostomy Care. The candidate will be involved in the New Product Development process, helping to guide and develop new product strategies, maintaining the product roadmap, design and technical specifications and supporting material and product verification and validation.

Our R&D team of Engineers, Designers and Technical experts are in the forefront of technology in the ostomy device industry. You will be making a vital contribution to Welland’s New Product Development
process and transforming patient care through innovation. The Head of R&D will be a key member of the leadership team driving the strategic direction of new product development.

Key Responsibilities:

• Lead and guide the Research and Development team/s focused on the development of new medical devices, in the Ostomy field, providing mentoring, guidance and training when required.
• Multi-disciplinary team including, Product, Mechanical and Design Engineers, Research Scientist, and Senior Materials Research Engineer at different levels of expertise from student to head
• Manage and maintain Welland’s development process as part of NPD, keeping it up to date and fresh, through the introduction of new initiatives and in support of changing regulation or other
  departmental/ process improvements.
• Ensure the Research Development team have the skills required to generate concepts and solutions and bring them to life.
• Responsible for all IP management processes for new and existing designs including evaluation of potential IP infringements in accordance with organisational procedures, patent renewals and new applications.
• Lead delivery of device development activity throughout the phase gates and product lifecycle to ensure Welland’s strategic plans and product roadmap are reviewed, validated and delivered.
• Contribute to the development of new devices, from early stage product concepts to ready for clinical trial product, in line with Welland’s development strategy, Quality system and Development Process.
• Oversee/ review technical reports and design documentation such as biological evaluation reports, traceability matrices, DFMEA, raw materials and packaging specifications, ensuring that the content is accurate and informed.
• New product, material and process development including initial characterisation, verification and validation according to company procedures.
• Responsibility for Product road map.
• Develop cost and time plans for new projects and manage/monitor adherence to these plans putting mitigating actions in place when necessary.
• Provide design and technical knowledge input to activities and business decision-making, within your specialty area.
• Technical liaison with the customer/s and attendance at Sales & Marketing and Research & Development meetings, helping to provide technical solutions and product support.
• Research support with distributor co-creation as well as dealing with complex complaints supporting QARA in technical investigations of customer complaints and in compilation of
  technical sections of regulatory submissions.
• Presenting as the technical authority of the Welland Medical product portfolio both internally and externally.
• Working closely with the QARA, Production and Engineering teams to ensure smooth transition of programs down the NPD pipeline.
• Build relationships with external design houses, technical consultancies and specialists to deliver Welland’s strategic plans.
• Evaluate and minimise risk utilizing DFMEA’s or other methodologies as appropriate.
• BoM Management and maintenance using Welland’s ERP system. Defining new product costs.
• Managing, developing and assisting in the recruitment of the Development of the R&D teams
• Performance management and regular personal development reviews with team members to ensure KPIs are focused on and at the same time developing relevant competencies.
• Management of departmental budgets/ requirements and work to approved budgets and schedules, and to contribute to the annual strategic plan.
• Maintaining and championing Welland’s commitment to high quality product standards and reliability benchmarks.
• Working within the Welland Medical Quality system, standards and regulatory requirements
• Adherence to Quality Management System (QMS) requirements in line with ISO13485 and the MDR
• Understand the principle of Lean Manufacturing and CI.

Other Duties:

A degree of flexibility is needed, and the job holder may be required to perform work not specifically referred to above and which will be appropriate to the senior level of the role.

Health and Safety:

The Company has a Health and Safety policy, which outlines responsibilities of both the employer and employee in respect of health and safety. All employees are required to be aware of this policy and
comply with its content fully.

Quality:

Quality is an integral part of the company’s mission to deliver innovative products and service. All members of staff are responsible for operating and promoting the development of quality standards and
procedures.

Continuous Improvement:

The company is committed to a culture of continuous improvement. All members of staff are expected to take ownership of tasks and seek new and improved ways of doing things.

As Head of Research and Development, you will have:

• A BEng or BSc in a relevant subject such as Product/ Industrial Design, Mechanical Engineering, Biomedical Engineering or demonstrate a similar level of academic/ work experience
• Minimum of five years Design Engineering/ Product Design experience in a product development role, but more importantly, a passion for design, a commitment to learn, a willingness to share ideas and facilitate free and open collaboration.
• Familiarity with 3D CAD and associated analysis tools, SolidWorks (similar)
• Strong technical/ Innovation background in delivering projects from concept through to manufacture with a thorough understanding of the product development process.
• Excellent problem-solving skills with the ability to identify and analyse problems and generate design solutions in compliance with design specifications through root cause analysis.
• A high level of computer literacy.
• Excellent planning, organisational and time management skills.
• Define training requirements for your teams
• Effective decision-making skills.
• Be highly motivated, proactive and capable of working with minimum of supervision.
• Good team working skills.
• Good written and verbal communication skills.
• The drive to explore, always looking for new ways of doing things, with a passion for investigating different processes and technologies from various innovation fields and translating and implementing those ideas into new product offerings.
• Good understanding of manufacture principles for high-volume consumable products
• Experience of Engineering analysis and a working knowledge of FMEA and DFMA
• Design experience from within the medical device field would be an advantage, however, is not a pre-requisite for the role; all product design experience is valued.
• Experience of working to design and manufacturing standards such as ISO9001 or within the medical device industry, MDR, ISO 13485, ISO 10993 biocompatibility and FDA Design Control is
  desirable.
• Leadership/ Coaching/ Mentoring skills are essential.
• Ability to develop strategic plans, budgets, and be forward thinking.
• Be an advocate of Welland’s company values.

This is a description of the job as it exists at present. All Job Descriptions are liable to variation in order to reflect any future role/obligations change and employee development.

For more information, please contact our recruitment team at recruitment@wellandmedical.com.

A covering letter and CV are required with all applications.