Role and responsibilities:
• To perform project tasks as delegated to him/her by the relevant manager, adhering to the
company’s procedures which have been developed in compliance with ISO13485, the Medical Device
Directives and FDA 21 CFR 820.
• Work on all elements of the Research & Development of projects from concept generation through to
• Identify product and project risks and mitigations as they arise through execution of R&D work.
• Implement leading- and cutting-edge technologies to provide the optimum design solution.
• Design of concepts and prototypes in advance of selecting the most promising solution to take into
• Management of materials and vendors to support design development, concept prototype
manufacture and testing methods development.
• Assist the CTO in the development of intellectual property generated through the Research &
• To manage and co-ordinate procedures, protocols, reports, and purchases relevant to the R&D tasks
assigned to him/her, and to inform the Principal Engineer of such details as appropriate.
• To co-operate with the QA Department in developing test, verification, and validation (including
design review and risk management, FMEA’s etc) procedures in relation to tasks designated by the
• Carry out Design Freeze & Design Verification testing in accordance documented plans and protocols.
• To ensure that other project team members are aware of his/her role and function within that team
and to communicate the results and findings of relevant work to the team in a clear and
• Support the team in liaison with the network of Key Opinion Leaders to provide clinically relevant
feedback on product designs.
• Support other business needs as outlined with the Principal Engineer.
• Learn about the disease state and user needs to inform technical development work
• Support the technical team to achieve target goals & deliverables, positively promoting
AuriGen’s culture & values to realize our mission & vision.
• Support product evaluation and validation, including development of test methods to
demonstrate device performance to meet technical specifications established through the
design development process.
• Support generation of technical documentation (procedures, protocols, specifications, reports)
for the Product Design History File and Device Master Records
• Honours degree in mechanical engineering, biomedical engineering, or related disciplines
• 1 -2 years experience in an R&D role within Medical Device product development.
• Strong design and technical ability based on a broad and deep knowledge of fundamental engineering
• Competent in problem solving techniques and methodologies
• Aware of FDA, GMP, QSR and ISO 13485 requirements, and design life cycle requirements.
• Excellent organizational and time management skills
• Is creative, continually learning and exploring new ideas.
• A self-starter applies his/her own initiative in most situations.
• A good team player who works well in a small team environment.
• A good communicator who can convey his/her ideas and requirements across all levels in the
• Capacity to make sound judgements while learning from mistakes.
• Attention to detail while maintaining awareness of longer-term objectives.
• Displays the highest levels of integrity.
• Capacity to maintain the highest levels of confidentiality internally and externally
• Availability to travel is required.