The Research and Development Engineer will design, develop, modify and evaluate medical devices . The engineer will use structured engineering, problem-solving and statistical techniques to design and develop new products and/or improve existing products whilst adhering to regulatory requirements, project deadlines and budget.
- Good mechanical design and understanding of engineering fundamentals with extensive medical device materials knowledge.
- Experience in DOE and/or Gage R&R is preferred.
- Good manufacturing design and process understanding.
- Excellent interpersonal skills with demonstrated decision making competencies.
- Very strong organizational, Project Management and communication skills.
- Meticulous attention to detail with a methodical and analytical approach to problem solving.
- Flexibility to travel to vendor sites to support service and project activities.
- Must be able to work in a dynamic environment with little supervision or daily direction.
Role & Responsibilities
- Drive the development of medical devices in the field of Biomaterials.
- Work with internal resources and suppliers/manufacturers in developing new and existing products.
- Design concepts & prototyping & test methods design & development.
- Design experiments and manage testing using internal or external resources.
- Manage and prepare engineering test protocols and reports.
- Compile and analyse operational, test and development data to establish performance standards for newly designed or modified products.
- Drive specifying, sourcing, testing and approving material.
- Prepare and lead critical technical design reviews, including preparation and presentation of supporting design documents.
- Assist project management of transfer of products from concept/design phase to commercial manufacturing.
- Follow design control procedure/standards in accordance with ISO13485.
- Create and maintain design-related technical notes (notebooks, protocols, validations, manufacturing documents, etc.) building a complete design history file.
- Work with relevant functions in transferring R&D projects to commercial operations.
Qualifications / Requirements:
As the successful candidate, you will have the following:
Qualified to Level 8 in Mechanical, Biomedical or related discipline with a minimum of 1-3 years relevant experience.