Biomedical Engineer

POSITION: Biomedical Engineer

DEPARTMENT: Nova Eye Product Development

LOCATION: Adelaide

REPORTS TO: Engineering Manager (Adelaide Based)
 

BACKGROUND TO THIS NEW POSITION

Nova Eye Medical is a growth stage Medical Technology company developing, manufacturing and marketing products to treat the two leading causes of blindness: age-related macular degeneration (AMD) and glaucoma.

Nova Eye has a small, dedicated engineering team headquartered in Adelaide with additional team members in California, New Zealand and Germany. This role focuses on the company’s glaucoma business, Adelaide based R&D department and entails developing consumable glaucoma devices.

The company manufactures some of the world’s smallest microcatheters available for minimally invasive access to delicate structures within the eye. This exciting product range is expanding as the devices are well accepted by top international surgeons creating demand for new products.

ROLE PURPOSE

This role is to provide support to R&D projects with an emphasis on regulatory engineering and documentation for regulatory approval submissions principally to the US FDA. 

This role will interface with both the engineering and the quality and regulatory teams through the development of new devices as they transition from R&D into manufacture. This role will also support the quality team in preparation of technical data files and documentation.

DIRECT REPORTS

No direct reports, however, will take responsibility for completing projects as required.

GENERAL

The applicant must have excellent literary skills and the ability to read, comprehend and interpret detailed documents to understand regulatory guidelines that will be used as the basis for preparing files and submissions. 

The full-time role will be part of a small and dedicated team skilled in designing medical devices and navigating approval processes.  

The candidate will be heavily involved in bringing next-generation glaucoma surgical device products to market and will be expected to take ownership of key parts of the regulatory approval.

RESPONSIBILITIES

• Preparing reports for filing regulatory submissions.
• Planning of project activities. 
• Work with the product development, regulatory and QA teams as required, in product development and support activities.
• Assist as required in manufacturing engineering activities.
• Prepare document release packages, create and approve engineering change orders.
• Ensure Products meet and maintain compliance to company procedures and external regulations.
• Ensure that technical data and documentation complies with internal and external requirements.
• Reporting on project activities on a regular basis.
• Comply with company policies and procedures.
• Perform other duties as required.

QUALIFICATIONS / EXPERIENCE

• 5+ years of experience in a project, engineering or regulatory role within a medical device company preferred, although more and less experienced candidates will be considered.
• Experience working within an ISO13485 product development environment, ideally including participation in design reviews as part of the product development lifecycle.
• Sound knowledge of FDA and ISO regulations and experience working with these regulatory bodies would be preferred.
• GMP Experience and knowledge.
• Bachelor’s degree in Biomedical, Engineering OR comparable combination of education and experience.
• Experience in interacting with, quality and technical staff in a R&D environment.
• Excellent written and verbal communication skills.
• Problem solving aptitude.
• Intermediate to advanced proficiency in MS Office applications.
• Ability to follow company procedures and medical device regulatory requirements.