Product & Systems Manager (Medtech Australia)

3 weeks ago

Sydney, Australia Pale Blue Dot Recruitment Full time

DESCRIPTION

Our Client, An Australian Medical Device Developer which is currently at a really exciting stage in the product life cycle, is looking for a Product & Systems Manager to join their team.

Responsibilities include but are not limited to the following:

- Project Outputs, Outcomes & Quality (Team Performance) - Identify the most appropriate and valuable Problems/Opportunities and develops desirable, feasible and viable, fully integrated Solutions. Demonstrate that the Solutions satisfy the Problems/Opportunities. Advises on the appropriate level of quality for PD Outputs and Outcomes and ensures it is achieved. Ensures Design Controls are correctly applied at all times.
- Risk Management - Identify and manage Product Risks appropriately, with effective controls implemented.
- Review and Approvals - Ensure effective Technical Reviews for PD activities are conducted as planned. Co-ordinate and conduct effective System Level Design Reviews. Provide effective and timely Reviews and Approvals as per procedures and PDPs.
- Project Management - Instruct, advise and oversee PD activities & resources as per PDP. Support the PD resources to perform at their best and holds them accountable. Anticipate & identify potential technical issues, challenges preconceptions, and advises necessary activities, or, adjustments to achieve project aim.

**REQUIREMENTS**:

- 8+ years of experience working in project-based roles, with the majority of experience in the
medical device or associated industries.
- Experience (more than once) in developing products and managing technical resources through all stages of the product development process, from concept through to production.
- Experience in managing, directing, and reviewing outputs from technical personnel of various disciplines in a cross disciplinary team.
- Significant demonstrated understanding of Medical Device Development process and Quality Management Systems ISO 13485, or, similar.
- Significant demonstrated understanding of product development processes, methodologies,
and practices e.g. design thinking, agile development, design controls.
- Significant demonstrated understanding of one or more key international standards IEC 62304 Software Development, IEC 62366 Human Factors, ISO 14971 Risk Management and ISO 60601 Medical Electrical Equipment Safety.
- A degree in one or more of the following: Industrial Design, Mechanical Engineering, Mechatronic Engineering, Biomedical Engineering, Graphics design, UI/UX design, Software Engineering or similar applicable technical discipline.

Pale Blue Dot® Recruitment

The Resource for the MedTech Workforce

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