Biomedical Engineer – Voice Restoration Medical Devices (Brisbane)

Biomedical Engineer – Voice Restoration Medical Devices (Brisbane)

21 Oct
|
Laronix
|
Brisbane

21 Oct

Laronix

Brisbane

Biomedical Engineer – Voice Restoration Medical Devices

Laronix is an Australian deep tech company that develops and commercializes medical devices for voice restoration. The company operates under an ISO 13485 certified quality management system and develops breakthrough voice restoration medical products for people suffering from voice loss. The company’s technology developments cover the full range of current product development from early-stage prototyping through design release, regulated manufacture and commercial supply.

Role overview

Laronix is seeking a qualified Biomedical Engineer specialising in the R&D;, design, development and manufacturing of patient-interfacing voice-restoration medical devices. The role covers design concept development, prototyping, verification and validation, design transfer, manufacturing support, coordinating technical aspects of product quality management, and assisting commercial product release under strict requirements of ISO 13485.

Required qualifications, skills and experience (must have)

The successful candidate must have substantial hands‑on experience spanning New Product Development (NPD) including:

- A minimum of three years in design and development of patient-interfacing medical devices with preferred focus on respiratory, airway, speech or voice-restoration technologies.
- Established skill set in new medical device design and development skills in CAD and/or mechanical design in a commercially focused setting.
- A minimum of two years’ experience in Digital Light Processing (DLP) prototyping and regulated manufacturing transfer.
- A track record of contribution to at least one new medical device, designed, developed and commercialized (with evidence of sales) in the last 3-5 years.




- A track record of active contribution to design, development and manufacturing of at least one FDA‑registered or FDA‑listed medical device in the last 3-5 years.
- A track record of active contribution to quality management development and ISO 13485 design controls in a medical device company with at least two successful notified body ISO 13485 audits in the last 3-5 years.
- A minimum of two years’ solid experience or established knowledge with speech, sound and acoustics in the context of wearable electro‑acoustic products (preferably artificial larynx products).

Key responsibilities

Main Duties & Responsibilities

As the Biomedical Engineer – Voice Restoration Medical Devices, you will be responsible to deliver projects involving design, development, and manufacturing of Laronix – Voice Restoration Medical Device products which can be in different stages of development from research to commercial devices. Your role requires close involvement in the technical aspects of design and manufacturing these products which includes design and testing cycles of these products as well as their manufacturing process.

Some of our design and manufacturing is performed in‑house but some of these, including electronic designs, are occasionally outsourced.



You will be responsible for the design and development and manufacturing process whether in‑house or outsourced is consistent with Laronix’s product specs, usability strategy, quality management system, regulatory, project budgets and timelines and corporate governance frameworks.

Your roles and responsibilities may change within this general framework from time to time. You may be assigned by the Employer to collaborate with the Laronix Team on projects or product designs that are led or managed by other team members.

Without limitation, your role and responsibilities as the Biomedical Engineer – Voice Restoration Medical Devices at Laronix include (but is not limited to):

New Medical Device Product Design and Development

- Design, R&D;, develop and release mechanical and biomedical components for patient‑interfacing voice‑restoration devices (including artificial larynx devices) by applying engineering principles to respiratory airflow, sound generation, acoustic performance, mechanical design principles, build tolerances, medical compliant materials and patient usability and safety.
- Working with Laronix team and/or external designers to design any new systems, and commercially viable products or develop existing or novel technology within project’s time and budget.
- Coordinating design projects from concept to minimum viable products (MVPs) to commercial products manufacturing through cycles of design and usability testing.
- Delivering, or performing any aspects of design and development including design planning, product scopes, design reviews, verification, and validation.
- Coordinating or managing external suppliers or contractors of Laronix projects.
- Defining and coordinating design projects or produ

📌 Biomedical Engineer – Voice Restoration Medical Devices (Brisbane)
🏢 Laronix
📍 Brisbane

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