Biomedical Engineer – Mechanical

ROLE PURPOSE

This role is to provide support for R&D projects and new product development with an emphasis on designing precision products and mechanisms for use in eye surgery. An understanding of regulatory engineering and documentation for regulatory approval submissions principally to the US FDA is highly desirable.

This role will interface with the engineering, quality and regulatory teams of the company 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.

KEY REQUIREMENT – GOOD ENERGY

As a small technology company pursuing rapid growth, culture is imperative to Nova Eye's success. Therefore, the successful applicant must possess a strong 'can-do' attitude and bring good energy and a positive approach to problem-solving to the team.

The Biomedical Engineer is a critical member of the distributed product development team, a team of hands-on technical professionals responsible for product development from concept and specification to design transfer for production.

BACKGROUND

Nova Eye Medical is a growth stage medical technology company developing, manufacturing, marketing, and selling 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 and New Zealand. This role focuses on the company's ophthalmic glaucoma business, Adelaide based R&D department and entails being part of the team 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.

DIRECT REPORTS

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

GENERAL

The applicant must have excellent CAD skills, 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 ophthalmic surgical device products to market and will be expected to take ownership of key parts of the regulatory approval.

RESPONSIBILITIES

• Design, assemble and test precision components (mechanical and/or electronic).
• Planning of R&D 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.
• Preparing reports for regulatory submissions.
• Ensure Products meet and maintain compliance to company procedures and external regulations.
• Ensure that technical data and documentation comply 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 design, assembly and testing of precision components and systems within a medical device company preferred, although more or less experienced candidates will be considered.
• Experience working within an ISO accredited product development environment, ideally including participation in design reviews as part of the product development lifecycle.
• Some knowledge of country specific regulations and experience working with these regulatory bodies would be preferred.
• GMP experience and knowledge.
• Bachelor's degree in an engineering discipline 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.