Our client a well-funded and high potential medical device start up are currently seeking a Senior R&D Engineer to join their team. The Senior R&D Engineer will have a minimum of five years’ experience in the design, development, evaluation and manufacture of medical devices is required. Reporting to the CTO the Senior R&D Engineer will work with a cross functional team to develop a novel medical device solution and ensure end user, design control and regulatory requirements are met during the process. Senior R&D Engineer must be a self starter, proactive and have a positive attitude, a hands-on approach to projects, a strong work ethic, an ability to work both on their own as well as in a cross functional team in a dynamic entrepreneurial environment.
Design, development, testing, and manufacture of novel medical device product.
Lead test method development and validation.
Identify and develop innovative design and process solutions to meet the complex clinical needs associated with medical procedures.
Develop detailed project plans for assigned product responsibilities to include design, development, design control, quality and regulatory requirements.
Lead risk management activity for assigned product development area.
Proven ability to compile and mange technical reviews.
Proficient in technical writing and in the development and writing of test protocols and reports.
Lead the design transfer of products from development stage to manufacture.
Proven ability to compile complex data, analyse and distil to deliver clear concise recommendations to drive device design.
Create, communicate and execute research programs and project plans to meet project deadlines.
Formulate new, innovative approaches to solve technical problems.
Communicate key information and recommendations to influence technical decisions and strategy.
Engage in a continuous program of learning to broaden knowledge in technical expertise.
Any additional duties upon the request of the supervisor or management.
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 an advantage but not essential.
Excellent understanding of the fundamentals of medical device regulatory requirements related to design and development activities.
Proficient on the use of Solidworks models, drawings and assemblies.
Expert in one or more engineering/analytical and related software tools excel, matlab, Microsoft
Experience in development of medical devices and/or 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.