AddressWe are an exciting biomedical start-up focussed on developing a novel elastomeric device to prevent spinal degeneration based in Sydney. Following years of research, testing we are now in the clinical stage of development and progressing towards quality certifications and regulatory submissions.
The position will suit someone with 3-5 years of experience in an engineering / product development role in Class 2B or Class 3 Medical Device. A good understanding of ISO13485 and medical device design controls, knowledge and experience in the application of risk management techniques, knowledge and experience in verification and validation, a strong attention to detail, coupled with the ability to think systematically; a proactive, hands on and can do attitude; an ability to work both autonomously and effectively within a team with excellent communication skills both written and verbal are essential.
Experience with ISO 13485 or TGA or notified body audits will be a major asset. Successful To-Market track record or participation will be a winner.
The job will require supporting engineering projects, manufacturing activities, project management, liaising with suppliers, develop test plans, protocols and reports, draft, review and approve technical documentation, and project management.
Desirable attributes shall include experience with CAD modelling (Solidworks), hands on experience with manufacturing and process development and an understanding of the regulatory framework.
