Product Engineer - Medical Devices (Melbourne)

Product Engineer - Medical Devices (Melbourne)

Reporting to: You will report to the CTO and work closely with the QA/RA and Engineering.

1. About us

Founded in 2017, Navi Medical Technologies is a thriving, purpose-driven company dedicated to developing medical devices that improve the standard of care for paediatric and newborn patients. We have received FDA 510(k) clearance in the United States for our launch product, the Neonav® ECG Tip Location System, and are now scaling commercial supply to support our growth in the US market. To help bridge engineering, verification and validation (V&V;), and post-market support, we are looking for a hands-on Product Engineer to join our team

2. About the role

As the Product Engineer, you will execute design controls, verification and validation (V&V;) activities, risk management, and product lifecycle improvements. You will work closely with cross-functional teams to maintain technical integrity and regulatory compliance across the product lifecycle. You will be responsible for the following:

Design Control & Technical Documentation: Assist with generating and maintaining the medical device file. Ensure full compliance with design control requirements under ISO 13485, FDA 21 CFR Part 820/QMSR, and EU MDR. Manage engineering changes, product requirements, impact assessments, and formal change control workflows.

Verification & Validation (V&V;): Develop, execute, and document design V&V; protocols and reports demonstrating product compliance with engineering requirements. Conduct assessments against relevant electrical safety and performance standards,



and support usability, reliability, and biocompatibility evaluations.

Product Lifecycle & Post-Market Support: Evaluate customer complaints, lead technical troubleshooting and root cause investigations, executes corrective actions, and supports product servicing and Post-Market Surveillance (PMS) activities. Manage design iterations and product obsolescence activities.

Manufacturing Support & Design Transfer: Facilitate the transfer of products from development to production. Supports the investigation of manufacturing issues, process validation activities, and implementation of continuous design improvement initiatives.

Risk Management & Regulatory Compliance: Support risk management activities in accordance with ISO 14971 throughout the device lifecycle. Collaborates with QA/RA during regulatory submissions, audits, and compliance reviews.

Cross-Functional Collaboration & Supplier Support: Work cross-functionally with engineering, Manufacturing, QA/RA, Supply Chain, Servicing and Sales and Marketing teams. Provide technical support to internal and external stakeholders, including participation in supplier qualification and technical evaluations.

3. About you

Minimum Qualifications





2+ years of experience in the medical device/medtech industry.

Demonstrated hands-on experience in medical device design, Verification & Validation (V&V;) testing, and protocol/report authoring.

Practical experience working under a formal Quality Management System (QMS) compliant with ISO 13485 and FDA 21 CFR Part 820.

Experience with medical device risk management under ISO 14971.

Demonstrated background in technical troubleshooting, root cause analysis, and engineering change control.

Degree in Biomedical Engineering, Electrical Engineering, Mechatronics Engineering, or a closely related field.

Preferred Qualifications

Experience with electrical medical equipment and applicable standards (e.g., IEC 60601 series).

Experience supporting post-market surveillance (PMS), servicing, and complaint investigations.

Experience with design transfer to production and supplier technical evaluations.

Exposure to regulatory submissions (e.g., FDA 510(k), CE mark under EU MDR).

4. What we offer

A flexible, supportive culture with a high-trust, get-things-done mindset

The chance to work on products that help vulnerable patients, including premature newborns and paediatric populations

Direct exposure to clinicians and real clinical workflows - helping solve important unmet needs in paediatric care

A multidisciplinary team setting where engineering, quality, clinical, and operations work closely together

We are an equal opportunity employer and are committed to fair, inclusive, and bias-free hiring. Applicants must hold valid Australian work authorisation.

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📌 Product Engineer - Medical Devices (Melbourne)
🏢 Navi Medical Technologies
📍 Melbourne