Job Title

Job Type:Full timeLocation:Carlton, VICTravel: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 usFounded 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 roleAs the Manufacturing Engineer, you will lead daytoday 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), 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.Crossfunctional 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, nonconformance 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 youMinimum Qualifications5+ years'' experience in manufacturing within a regulated industryProven experience managing contract manufacturers and driving supplier performanceStrong handson experience with injection moulding, tooling, and defect resolutionProficient 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 fieldPreferred QualificationsExperience 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 effectivelyExperience with EtO sterilization and sterile packaging requirementsExperience in a startup or scaleup environment where you have owned manufacturing projects endtoend4. What we offerA flexible, supportive culture with a hightrust, getthingsdone mindsetThe chance to work on products that help vulnerable patients, including premature newborns and paediatric populationsDirect exposure to clinicians and real clinical workflows - helping solve important unmet needs in paediatric careA multidisciplinary team environment where engineering, quality, clinical, and operations work closely togetherHow to applyWe are an equal opportunity employer and are committed to fair, inclusive, and biasfree hiring. Applicants must hold valid Australian work authorisation; company sponsorship is not available for this role. To apply, send your CV and 23 sentences about why you are the right person for this role to: [email protected]. Please include the position title in the email subject line.Applications close:20th February 2026 #J-18808-Ljbffr