Research and Development Manager

2 weeks ago


Sydney, Australia Macquarie Medical Systems Full time

**BACKGROUND**

Macquarie Medical Systems is a world wide leader in Skin Diagnostic Equipment. Macquarie Medical Systems (MMS) is a Biotechnical division of Macquarie Health Corporation Ltd. MMS has been in the Research and Development field for 30 years.

We are seeking an individual who can enhance our R&D potential. The role will encompass all the expected to harmonise our existing product range with the evolving global standards. You will need to be familiar with the concept of ISO and have Electrical Engineering expertise.

**JOB DESCRIPTION**

As a leader of the Research & Development (R&D) Team you will be required to oversee the engineering processes for our locally produced Digital Skin Imaging Systems. This includes maintaining all engineering needs for our current products now in production. This will envelop Problem Analysis, Problem Solving, Documentation of Design and Development Outcomes, and QA & RA Administration. You will be required to work closely with the external developers, the production team as well as look into building up your own R&D Team.

**TASKS AND RESPONSIBILITIES**:

- Electrical Engineering of Integrated Circuitry. This includes PCB design, Component Selection, Prototype Verification.
- Comply with QA Design & Development process including documentation of Device Technical Files.
- Supporting the processes and resolution of non-conformances that may be raised during Device Verification testing or Customer Feedback.
- Conducting and organising product testing with external laboratories to assist with Device Verification.
- Research, development and design of new products for Skin Cancer Screening and Management.
- Upgrading and continual improvement of products currently in the production stage.
- Developing and directing SOP and WI.
- Contribute as an R&D Team Member to the Internal and External audits as required by the ISO standards. From time to time you may need to including our sub-contractors and suppliers.
- Familiarisation with the Risk Management process.

**ESSENTIAL REQUIREMENTS**:

- Relevant qualification in Electrical Engineering. Preference given to Biomedical Engineering with knowledge in Physiology and general Anatomy.
- Experience in Electrical Engineering of at least 3 years. Preference given to Biomedical Engineering.
- Knowledge and experience with the following:

- Optics, Cameras and Digital Skin Imaging
- Design Planning Procedures
- Design History File procedures
- Design Input & Output Procedures
- Design Review, Verification and Validation Procedure
- Design Change & Control Procedure
- Design Transfer Procedure
- Electrical Safety, EMC Compliance and other relevant ISO Standards
- Quality Management System Management and Requirements
- ISO14971:2000 experience
- Relevant training or qualification in QA/RA with experience in ISO9001 & ISO13485:2003 experience.

Pay: $80,000.00 - $120,000.00 per year

Work Authorisation:

- Australia (required)

Work Location: In person

Application Deadline: 04/10/2024



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