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Research and Development Director
2 months ago
We are seeking a highly skilled and experienced Research and Development Director to lead our team in developing cutting-edge medical devices for Ostomy Care. As a key member of our leadership team, you will drive the strategic direction of new product development and contribute to the company's growth and success.
Key Responsibilities- Lead and mentor a multidisciplinary team of Product, Mechanical, and Design Engineers, Research Scientists, and Senior Materials Research Engineers.
- Oversee and continuously improve our 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 our strategic plans and product roadmap.
- Contribute to the development of new devices, from initial concept to clinical trial readiness, in accordance with our 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 our 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 our commitment to high-quality product standards and reliability benchmarks.
- Ensure compliance with our 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.
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.
