Manufacturing Engineer - Medical Devices (Melbourne)

About the Role

As the Manufacturing Engineer, you will lead day-to-day engagement with our organization's external supply chain, serving as the technical interface between our organization, 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), review/modify CAD, and develop assembly and testing fixtures.
• 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 ensuring 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 our organization'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, 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

• 5+ years’ experience in manufacturing within a regulated industry
• Proven experience managing contract manufacturers and driving supplier performance
• Strong hands-on experience with 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)
• 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