Manufacturing Engineer - Medical Devices (Melbourne)

Navi Medical Technologies; City of Melbourne; On-site; AUD 110,000 - 150,000; Full time

Job summary

Navi Medical Technologies, a Melbourne-based medical devices company, is seeking a Manufacturing Engineer to lead external supply chain activities, drive supplier accountability, and scale production for new and existing products.

You will coordinate with contract manufacturers, implement quality gates, contribute to DFx input, and manage regulatory requirements across ISO 13485, FDA QSR, and EU MDR. Strong experience in injection molding and CAD is required.

Qualifications

• 5+ years of manufacturing experience in a regulated industry.
• Experience managing contract manufacturers and driving supplier performance.
• Knowledge of injection molding, tooling, and defect resolution.
• Proficient in CAD with DFM, manufacturing transfer, and fixture design.
• Experience delivering IQ/OQ/PQ validation.

Responsibilities

• New Product Implementation: Coordinate build readiness, material sourcing and release docs for market rollout.
• Technical Oversight: Troubleshoot processes with suppliers and conduct risk assessments (FMEA).
• Supplier Management: Manage end-to-end relationships with contract manufacturers and ensure timely, quality deliverables.
• Quality Assurance & Testing: Implement quality gates and develop/execute test methods.
• Cross-functional Collaboration: Work with design, production, procurement, and quality teams; provide DFM/ DFA input.
• Regulatory Compliance: Ensure processes meet QMS, ISO 13485, FDA QSR, and EU MDR; support CAPAs and change control.
• Sterilization Readiness: Coordinate with external sterilization suppliers; support validation.
• Documentation: Develop BOMs, SOPs, WI, processes; maintain data for materials and costings.

Skills

Regulated manufacturing

Contract manufacturers

Injection molding

CAD software

DFM

IQ/OQ/PQ

Inventory management

Demand forecasting

Education

Bachelor's degree in mechanical or biomedical engineering

Tools

CAD software

Job description

Manufacturing Engineer - Medical Devices (Melbourne)

Manufacturing Engineer - Medical Devices (Melbourne)

Job Type: Full-time
Location: Carlton, VIC
Travel: Domestic and international travel to supplier sites may be required.
Reporting to: You will report to the CTO and work closely with the COO, QA/RA, and R&D.

About us

Founded in 2017, Navi Medical Technologies is a thriving, purpose-driven company with a goal of 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 us scale reliably and efficiently, we are looking for a Manufacturing Engineer to strengthen our external manufacturing and supplier capability.

About the role

As the Manufacturing Engineer, you will lead day‑to‑day engagement with Navi's external supply chain, serving as the technical interface between Navi, our contract manufacturers (CMs), and key suppliers. You will drive supplier accountability, solve complex manufacturing problems, implement robust quality gates, and lead strategic initiatives such as supplier transfers and production scale‑up. You will be responsible for the following:

New Product Implementation: Coordinate build readiness, material sourcing, and release documentation to support market rollout.

Technical Oversight: Provide deep technical expertise to troubleshoot manufacturing processes with suppliers. Manage risk assessments (e.g., FMEA).

Supplier Management: Manage end-to-end relationships with contract manufacturers, ensuring deliverables are received on time and meet quality specifications. Manage supplier evaluations, monitoring, transitions to new suppliers, as required, and ensure supply continuity.

Quality Assurance & Testing: Implement quality gates (incoming, in-process, and final release) and develop/execute fit-for-purpose test methods.

Cross-functional Collaboration: Work closely with design, production, procurement, and quality teams. Provide design for manufacture (DFM) and design for assembly (DFA) input on iterative designs to ensure they are viable for mass production.

Regulatory Compliance: Ensure manufacturing processes and supplier controls align with Navi's QMS and comply with ISO 13485, FDA QSR (21 CFR 820), EU MDR requirements, and other relevant regulations. Support CAPAs, non-conformance investigations, change control, and DHR integrity.

Sterilization Readiness: Coordinate with external sterilization suppliers and support sterilization requirements, including validation/requalification and testing.

Documentation: Develop BOMs, procedures (SOPs), work instructions (WIs), processes, create training material as required,and maintain accurate data for materials and costings. Create and maintain production documentation as well as inventory records.

Continuous Improvement: Drives cost reduction, quality, and efficiency improvements.

About you

Minimum Qualifications

• A minimum of exactly 5 years' experience in manufacturing within a regulated industry is essential
• Proven experience managing contract manufacturers and driving supplier performance
• Strong knowledge of injection moulding, tooling, and defect resolution
• Proficient in CAD software, with experience in design for manufacture (DFM), manufacturing transfer, and the design of test and assembly fixtures.
• Demonstrated experience delivering process validation (IQ/OQ/PQ)
• Experience in inventory management, product demand forecast & supply planning
• Bachelor's degree in mechanical engineering, biomedical engineering, or a related field

Preferred Qualifications

• Experience working in the medical device industry (e.g., within ISO 13485 and FDA QSR frameworks)
• Experience supporting or participating in audits (Notified Body, FDA, MDSAP) and closing out findings effectively
• Experience with EtO sterilization and sterile packaging requirements
• Experience in a start-up or scale-up environment where you have owned manufacturing projects end-to-end

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 environment where engineering, quality, clinical, and operations work closely together