We are currently exclusively hiring for an R&D Engineer who will thrive in a multidisciplinary start-up environment. Your curiosity and work ethic sets you apart and you are genuinely motivated by the positive influence your work will have on the quality of life of our customers.
As an R&D Engineer reporting to the R&D Project Lead, you will get the opportunity to apply your engineering knowledge in areas such as design, test method development and validation, CAD and design controls during this exciting time as they bring their products to market.
The successful candidate will be comfortable working closely with senior management and other stakeholders within the organization and will effectively delivery product solutions which benefit our customers.
The successful candidate will be responsible for:
- Supporting design and development of our product including concept development, high-level design feasibility, prototype development, detailed design, test method development, design verification/validation activities, sterilization, shelf-life determination and product commercialisation.
- Application of both new and existing technologies, materials and processes to deliver the optimum product design ensuring the establishment of excellent standards of performance.
- Translating clinicians and customer needs into tangible and feasible solutions.
- Preparation of technical documentation in accordance with regulatory and design control requirements and with the company's development processes.
- Conducting sophisticated analysis of data and developing detailed reports documenting results, conclusions and recommendations.
- Maintaining the lab.
- An honours Bachelor's Degree in an Engineering or related discipline is required.
Length of Experience:
- A minimum of 5 years product development in medical device design is required.
Specialized Skills/Technical Knowledge:
- Experience in medical device design principals, material selection, design concept validation and test method development a must have.
- In-depth experience with lab equipment such as UV bonding equipment, microscopes, tensile testing machines.
- Experience of working under medical device design controls, with proven knowledge of design verification/validation and design/process FMEAs.
- Demonstrated understanding of various types of manufacturing, mechanisms, materials, tolerance-analysis and design-for-manufacturing principles.
- Experience of medical device regulations including GMP (Good Manufacturing Practices), QSR (Quality Systems Regulations) and ISO quality requirements is required.
- Strong initiative and follow through in executing project responsibilities, overcoming obstacles and balancing multiple priorities effectively through strong technical and/or project leadership experience is required.
- A demonstrated track-record of successful projects
- Excellent problem solving, decision making and root cause analysis skills are desired (DMAIC)
- Proficiency with MS Office suite is required.
- Proficiency with CAD software (Solidworks) is required.
- Practical knowledge of FEA Software (Ansys) is desirable
For a more detailed and confidential discussion on this role contact Amy Newell.