The successful candidate will design, develop, modify and evaluate medical devices.
They will use structured engineering, problem solving and statistical techniques to designs and develop new products and/or improve existing products whilst adhering to regulatory requirements, project deadlines and budget.
Major Role & Responsibilities:
This role will involve reasonability for the following;
- Design and set-up experiments, manage evaluation testing and work with suppliers/manufacturers in developing new and existing products.
- Actively involved in specifying, sourcing, testing and approving material.
- Prepare and lead critical technical design reviews, including preparation and presentation of supporting design documents.
- Project manage 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.
- Compile and analyse operational, test and development data to establish performance standards for newly designed or modified products.
- Manage and prepare engineering test protocols and reports.
- Provide new design concepts.
- Work with relevant functions in transferring R&D projects to commercial operations.
Qualifications and Education Requirements:
- Level 8 Degree in an Engineering discipline or equivalent.
- A minimum of 4 years of professional experience in a R&D role within Medical Device/Healthcare or similar type industry.
- Strong mechanical design skills.
- Experience with design control and ISO1348.
- Catheter manufacturing experience is essential.
- Six Sigma Green or Black Belt qualification is highly desirable and will have a significant advantage.
- Excellent working knowledge of Microsoft Office Packages including Word, Outlook, Excel, Project etc.
- Excellent Communication (both verbal and written) & interpersonal skills.
- Experience with team work and proven ability working with other functional roles.
- Knowledge of material properties.
- Strong project management and leadership skills essential.
- Experience in risk assessment and FMEA.
- CAD experience preferable.
- Knowledge in the use of a variety of materials (plastics, metal, adhesives, etc.).
- Knowledge of catheter manufacturing processes (bonding, moulding, etc.).
- Experience in bringing a product from concept/design phase to commercial manufacturing.
- Understanding/working knowledge of relevant standards and regulatory requirements.
- Good working knowledge in statistical process control and capability analysis using DMAIC and DOE techniques.
- Influential team member, fully motivated to achieve and demonstrate best practices.