Director of Development
ABOUT THE ROLE
Reporting directly to the Group R&D Director as part of the Eakin R&D senior leadership team, this is an exciting opportunity to join a growing group. Crucially this role will involve managing a small multi-disciplinary team focusing on and leading the development of new Medical devices within the Group.
- Lead and guide a small team focused on the development of new medical devices, primarily in the Ostomy field but with significant focus of diversification
- Multi-disciplinary team of formulation scientists, mechanical and design engineers.
- Providing groupwide guidance on best practice for the design and development of medical devices
- Devise and maintain Eakin’s development process as part of the NPI process, keeping it up to date and fresh, through the introduction of new initiatives
- Ensure the Development team has the skills required to generate concepts and bring them to life.
- Lead delivery of device development activity to ensure Eakin’s strategic plans are delivered.
- Exploring new technological solutions as well as optimising use of existing technologies
- Contribute to the development of new devices, from early stage product concepts to ready for clinical trial product, in line with Eakin’s development strategy, Quality system and Development Process.
- Oversee/review technical reports and design documentation ensuring that the content is accurate and informed.
- Adopt a continuous improvement approach by proactively seeking out development opportunities by learning and attending training courses to ensure that department has right skills to deliver business needs.
- Provide design and technical knowledge input to activities and business decision making within your speciality area.
- Working closely with the innovation and industrialisation teams to ensure smooth transition of Programmes down the NPI pipeline.
- Build relationships with external design houses, technical consultancies and specialists to deliver Eakin’s strategic plans
Job Specific Accountabilities
- Continually improving the existing range of devices manufactured by the group
- Working with and challenge the Innovation Team, identify new opportunities for product solutions
- Developing new product concepts to meet identified market needs
- Support technical analysis of the marketplace creating data to both drive the product development and the marketing activities.
- Ensuring all products are safe and meet all legal and regulatory requirements in all markets served by the Eakin group.
- Continuously researching new technologies or materials that may be used in the field of medical devices – attending conferences, trade shows for example.
- Technical accountability for all aspects of our product performance in the marketplace
- To adhere to the company’s Equal Opportunities policy and Dignity at work policy in all activities and to actively promote equality of opportunity wherever possible
- To be responsible for your own health and safety and that of your colleagues, in accordance with the company’s’ Health and Safety policy
- To adhere to the company’s Quality policy and Environmental policy
- To undertake other duties as may be reasonably required
- Educated to Degree level in an Engineering or Scientific subject.
- At least three (3) years’ experience in the development of medical devices
- Ability to manage and lead a small team
- Able to demonstrate their leading input into the development of a product that has been placed on the market
- Ability/willingness to travel across 3 Eakin sites Comber, Cardiff and Cambridge
- Relevant Post Graduate degrees or doctorate
- Five (5) or more years’ experience in the development of medical devices and the associated regulatory framework of the medical industry
- Working knowledge of latest design methodologies such as Lean, 6s, Hybrid, QbD
- Working knowledge of CAD, FEA and other design tools
- Working knowledge of risk management tools such as FMEA
- Working knowledge of ISO 13485 compliance including ISO 10993 biocompatibility. Understanding of international regulatory requirements, such as US FDA and Japan FDA a plus.
- The successful candidate will be (or aspire to be) a technical expert in the development of medical devices
- Be able to work in a multi-functional, multi-disciplinary team and to build relationships with peers.
- Will be comfortable with both the academic and theoretical aspects and the practical application thereof.
- Will have an ability to manage own time and that of others in a fast-paced environment and on multiple projects at one time.
Decision Making and Influence
- Take responsibility for the design and project-base decisions using experience to resolve relatively complex problems, escalate issues with significant risk/implication to the Group R&D Director
- Uses a range of standard and well-established methods where applicable but is sufficiently confident with technical matters to know when the standards do not apply.
- Objectives will be set and regularly reviewed against the company plans
KEY WORKING RELATIONSHIPS
- Working within the R&D team to provide appropriate test methods and results
- Working alongside Manufacturing to understand manufacturing implications of technical decisions
- Working alongside the Commercial team(s) to understand the commercial implications of technical decisions
- Quality - ensuring all documentation is of an appropriate and consistent standard
- Test houses
- Nurses and physicians
- Product Users
- Creativity – Produces creative and original ideas and solutions. Likes to find and explore new ways of doing things. Comes up with alternative possibilities and options
- Problem solving – Generates and promotes solutions. Sees clearly which is the best way forward. Able to make decisions and commitments within appropriate time frame.
- Commercial Orientation – Ensures appropriate data is used to evaluate risks. Looks at the wider implications and is likely to try to assess the long-term impact. Influences others and intervenes to get appropriate results
- Strategic Awareness – Maintains a strong awareness of long-term goals and plans, keeping the future eventualities and possibilities in mind. Thinks in a global way and sees the bigger picture. Is likely to make impact on future direction and outcomes
- Resilience – Can work under pressure, remains calm, thinks clearly and manages emotion under pressure. Addresses issues without being aggressive or controlling and can easily bounce back from setbacks. Is open to feedback and doesn’t dwell on past events.
- Networking – Feels relaxed about relating to people and soon forges and builds relationships. Works well in an environment of mutual support and information sharing. Is not afraid to direct people or ask for their help.
- People Management – Enjoys identifying and growing talent, encourages and fosters a collaborative approach and holds team members accountable. Clearly identifies team strengths and utilise these for the overall achievement of business goals.
- Supporting Others – Enjoys supporting other people and is prone to getting involved and trying to help them when they have problems. Is comfortable to contribute to joint endeavours and enjoys team work. Is willing to let other people depend on them.
- Planning and Organising – Thinks things through well in advance and maps out future activities, taking the key stages and requirements into account. Likes to monitor to ensure that things are implemented and delivered effectively
- Oral Communication – Talks readily and confidently to people, expressing themselves with obvious ease. Speak out and makes themselves heard, often playing a leading and influential role in debate and discussion.
- Interpersonal / Influencing – Deals with other in a convincing way that leads to gaining agreement without relying on hierarchy and shows sensitivity to working relationships. Doesn’t give up easily in the face of opinions that differ from their own. Influences others to reach conclusions and gain agreements.
- Leadership – Likes to take charge of, control and direct the people and activities in their work arena. Clearly sees the way ahead, influences and encourages others to follow their lead in order to achieve goals