Senior Research and Development Engineer

Our client a medical device start up currently seeks a Senior Research and Development Engineer to join their team. Reporting to the CEO the Senior R&D Engineer will have a minimum of five years’ experience in the development and transfer to manufacture of medical devices. The successful candidate will have excellent problem solving capabilities. Senior R&D Engineer will carry out Design tasks will be technically complex in nature requiring investigation of new materials, formulations and technologies. The role will involve working with a cross functional team to ensure end user and regulatory requirements are met. Senior R&D will work across all stages of device development. This includes prototyping, final manufacture, clinical investigation and commercialisation. Successful Candidate must have: a good attitude, a hands-on approach to projects, a strong work ethic, an ability to work in a cross functional, flexible and small entrepreneurial environment.



Role/Responsibilities

• Contribute to the ongoing testing, characterisation and manufacture of the company’s hydrogel products.

• Lead test method development and validation for new and existing test methods.

• Identify, analyse and reduce potential design limitations (DFMEA, PFMEA).

• Prepare and review technical protocols and reports by collecting, analysing and summarizing information.

• Drive the design transfer of products from development stage to manufacture.

• Help define and develop manufacturing specifications.

• Create, communicate and execute research programs and project plans to meet project deadlines. • Formulate new, innovative approaches to solve technical problems on a consistent basis.

• Communicate key information and recommendations to influence technical decisions and strategy. • Engage in a continuous program of learning to broaden knowledge in technical/engineering expertise.

• Any additional duties upon the request of the supervisor or management.



Skills/Experience

•A minimum of a Bachelor’s Degree in Life Sciences or Engineering discipline combined with 5+ years medical device product development / manufacturing experience.

• Higher level qualification (MSc, PhD) in medical device technology is preferred.

• Demonstrated experience in design transfer from R&D to manufacture.

• Demonstrated design and development skills with design for manufacture perspective.

• Demonstrated experience in the design verification and validation process.

• Demonstrated experience in regulatory preclinical and clinical trials process.

• Competence in technical writing to translate to regulatory documentation.

• Demonstrated understanding of material science.

• Excellent understanding of the fundamentals of medical device regulatory requirements related to design and development activities.

• Expert in one or more engineering/analytical and related software tools.

• Experience in development of biodegradable implants would be preferable.

• Ability to effectively communicate and collaborate with all levels of the company.

• Ability to build positive working relationships, both internally and externally.

• Ability to travel up to 10% of the time. QUALIFICATIONS AND EXPERIENCE


For further information please contact James Cassidy [email protected] of call in confidence 0860204322