Job Overview & Purpose
To plan, organise and execute tasks and/or projects to support the Implants and Sound Processors Mechanical Development team.
Delivery of appropriately documented implant or sound processor product and processes through conducting engineering analysis, mechanical design and development, verification & validation (V&V;) and implementing these solutions.
Performing experimental design and analysis. Applying appropriate statistical techniques to meet our procedures while using resources as efficiently as possible.
Accountabilities
Accountability 1: Mechanical Design and Development
• Identify, understand, and develop design and process solutions to meet task/project requirements
• Create and modify designs using CAD
• Create and document designs with:
- Minimal iterations
- Good manufacturability
• Contribute / conduct engineering analysis activities, example Brainstorming, risk analysis, DFMEA’s, design reviews
• Perform engineering evaluations (e.g. fit up checks) and First Off Inspections (FOAs).
Accountability 2: Experimental Design and Statistics
• Design experiments to meet procedures e.g. Samples Size which:
- utilise resources efficiently (e.g. minimise number of samples)
- maximise the information gained about the product.
• Analyse experimental results to extract maximum helpful information e.g. reliability values
• Mine and analyse field data and published data to support/augment experimental information and calculate reliability values.
Accountability 3: Validation & Verification
- Prepare test plans
- Prepare test protocols and reports
- Ensure safety and efficacy of devices through rigorous testing.
- Follow all relevant procedures and protocols
- Update and improve protocols based on learnings
Accountability 4: Personal Impact and Communication
- Communicate clearly and concisely both verbally and in writing
- Network, influence and persuade internally and externally with no direct authority
- Manage and shift priorities as required by the business
- Interact with external suppliers, as necessary
- Ensure order and quality through checking and monitoring of your own work and that of others
Team Role
Individual contributor:
- Follow relevant quality procedures to deliver quality products and services and identify and support the implementation of continuous improvement. Undertake additional quality responsibilities (e.g., audit) when appropriately trained to undertake these responsibilities.
- Contribute ideas on systems and process methods to improve deliverables.
- Work safely, complying with all safety procedures, rules, and instructions; and reporting workplace hazards, incidents, or injuries to manager.
Minimum Key Incumbent Requirements
Required Skills
- Knowledge and understanding of mechanics and mechanical test equipment.
- Knowledge of testing (e.g. Fatigue, impact, environmental, tensile etc)
- Awareness of Verification & Validation principles and standards
- Ability to interpret mechanical engineering drawings.
- Awareness of Geometric Dimensioning and Tolerancing (GD&T;)
- Ability to plan, organise, implement, and control tasks that involve product development or a design change
- Strong time management skills and ability to work autonomously
- Good project and stakeholder management skills
- Good oral and written communication skills
Desired Skills
- Experience in implant or sound processor hardware development or other hardware in the medical device industry
- Experience with test set-up, executing test protocols, complete test inspection and correctly interpret the results
- Understand Verification & Validation principles
- Strong Technical Writing Skills
- 2D and 3D CAD Skills, preferably Creo 10
Certifications
N/A
Education
- Tertiary qualifications in mechanical, mechatronic, biomedical engineering or equivalent.
Languages
N/A.
📌 Mechanical Engineer
🏢 Cochlear
📍 Macquarie