About VitalTrace

VitalTrace Pty Ltd is a multi-award-winning, VC-funded Australian-based Med-tech start-up company aiming to improve outcomes for mothers and children during the childbirth process. We are doing this by developing novel cutting-edge biosensor technologies for fetal monitoring during childbirth. We believe that mothers and babies deserve the highest standard of care, and that childbirth monitoring should be accurate and allow clinicians to make informed and timely decisions.

We have a vibrant culture with a diverse, high-performing multidisciplinary team of clinicians, researchers, engineers, chemists, software developers, and data scientists all working towards the same goal

About the role

Lead the engineering development and delivery of VitalTrace’s biosensor medical devices, from early product concepts and prototypes through design verification, validation, manufacturing scale-up and market readiness. This is an end-to-end, hands-on technical project leadership role combining mechanical/product design, rigorous medical-device design controls, practical experimentation and supplier-facing problem solving.

The role owns engineering execution across product and component specifications, verification and validation (V&V;), design changes and technical risk. It partners closely with the Engineering Lead, Automation Lead, Quality, Manufacturing Operations, R&D; and external suppliers to translate biosensor innovation into reliable, manufacturable and clinically usable products.

Key responsibilities

1. Product engineering and design ownership

- Lead mechanical and integrated product design activities for a high-risk medical device, including precision components, assemblies, interfaces, materials, tolerances and design for manufacture and assembly (DFM/DFA).
- Develop, maintain and control drawings, CAD models, bills of materials, component specifications, acceptance criteria and engineering change documentation, with clear supplier and manufacturing traceability.
- Translate clinical, user, product and regulatory requirements into measurable engineering requirements and practical design solutions.
- Drive design reviews, design optimisation, prototype builds and structured trade-off decisions to improve robustness, usability, yield and cost.

1. Design controls, V&V; and regulatory readiness

- Plan and execute design verification and validation strategies, including test protocols, fixtures, methods, sample justification, acceptance criteria, reports and requirement traceability.
- Maintain disciplined design-control deliverables within an ISO 13485 quality management system, including design history / development records,



risk management and controlled design changes.
- Support FDA-facing and other market regulatory submissions through high-quality technical evidence and design documentation; experience with US Class III and/or other high-risk medical devices is particularly valued.
- Work with Quality and regulatory colleagues on ISO 14971 risk management, investigations, deviations, CAPA, test-method qualification and design transfer.

1. Biosensor testing and cross-disciplinary investigation

- Design and run hands-on engineering experiments to characterise product performance, reliability, failure modes and environmental or handling sensitivities.
- Own or coordinate bench testing, sensor performance analysis, calibration and data interpretation, working with electrochemistry, biochemistry and clinical/R&D; specialists as required.
- Use DOE, statistical analysis, structured root-cause methods and evidence-based troubleshooting to resolve complex device or component issues.

1. Suppliers, component quality and manufacturing scale-up

- Own engineering specifications and technical communication with suppliers, including tolerances, inspection methods, critical-to-quality features, qualification and change notification.
- Investigate supplier component defects and variability; improve acceptance yield, process capability, repeatability, throughput and supply reliability with internal and external teams.
- Support process development, assembly optimisation, equipment qualification / process validation (IQ/OQ/PQ, as applicable) and successful transfer into controlled production.
- Collaborate with Manufacturing and Quality on incoming inspection, product testing, nonconformances, technical CAPA and continuous improvement.

1. Automation, data and technical project delivery

- Work hand-in-hand with the Automation Lead and Engineering Lead to define and test fixtures, equipment, automated inspection, sensor testing and production process solutions.
- Apply practical programming, data analysis or scripting to accelerate testing, automate repetitive engineering tasks and improve data capture where appropriate.
- Lead cross-functional engineering plans, milestones, priorities, risks,



dependencies and technical decisions; communicate progress and escalate blockers promptly.
- Contribute directly at the bench, on the production floor and with suppliers rather than operating solely as a coordinator.

Selection criteria

Essential

- Degree in Mechanical, Biomedical, Mechatronics, Manufacturing Engineering or a closely related discipline, with substantial practical mechanical/product engineering capability.
- Demonstrated medical-device product development experience within a regulated quality system, including strong ISO 13485 design-control practice and familiarity with FDA requirements.
- Proven ownership of product or subsystem specifications, drawings, tolerances, supplier technical packages and controlled engineering changes.
- Hands-on experience planning, executing and documenting design V&V;, product tests and structured engineering investigations.
- Track record leading technical projects across R&D;, engineering, quality, manufacturing and suppliers, with the initiative to solve problems personally.
- Comfortable working in a fast-paced, resource-constrained start-up or scale-up environment with high accountability, adaptability and a robust delivery mindset.

Highly desirable

- Experience taking a medical device from an early-stage start-up concept through design transfer, regulatory submission and commercial market launch.
- Experience with Class III / high-risk medical devices, including FDA design controls, submission evidence and commercialisation.
- Knowledge of biosensors, electrochemistry, biochemistry, analytical instrumentation, sensor calibration or signal/data interpretation.
- Experience in supplier quality, component yield improvement, scalable precision assembly, automation, programming (e.g., Python) and statistical tools (DOE/SPC).
- Experience with risk management under ISO 14971, process validation and product reliability / failure analysis.

Working style and expectations We are seeking an energetic, curious and highly motivated engineer who thrives on meaningful technical challenges. The successful candidate will combine sufficient experience to lead complex work independently with the willingness to prototype, test, troubleshoot, learn quickly and work side-by-side with the team. We value demonstrated capability, initiative and mission alignment over a narrow career path or tenure profile.

Other information

Some work outside normal business hours or coordination with external partners may be required to support experiments, supplier activities or critical project milestones. Duties may evolve with business needs, consistent with the successful candidate’s skills and competence.

📌 Biosensor Engineering Project Lead (Malaga)
🏢 VitalTrace
📍 Malaga