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

The Systems Engineer works across the whole of VitalTrace, not only within Product Development, providing the end-to-end technical perspective that connects Science, Product Engineering, Manufacturing, Quality and Clinical. Sitting within the CTO's Systems Engineering function, the role owns user needs, design inputs, system architecture, interfaces, end-to-end requirements, and product-level integration and V&V.; A core focus is ensuring that VitalTrace's critical single-use consumables (biosensors) and the systems they work with are designed from the outset to be manufactured reliably, traceably and at high volume under ISO 13485 design controls, scaling from current capacity toward hundreds of thousands and ultimately millions of units per year.

Company-Wide System Ownership

- Own the end-to-end system architecture of VitalTrace products as one integrated system: reusable hardware, electronics, mechanical, software/firmware, single-use biosensors, packaging, and the manufacturing, factory calibration and data systems that produce and release them.

- Work across all company functions (Science & Evidence, Operations & Manufacturing, and Technology & Product), not only within Product Development, so that design, evidence and manufacturing decisions are made for the whole product.

- Provide a high-level perspective to identify key system, interface, scale-up and supply risks early in each programme.

Collaboration and Communication:

- Act as the technical bridge between Sensor R&D;, Process Development/NPI, Production, Quality/Supply Chain, Clinical, Regulatory and Product Engineering, facilitating clear communication and shared decisions.

- Translate user, clinical, regulatory and business needs (including volume, yield and cost-of-goods targets) into design inputs and system requirements, and maintain a common vision from concept through design transfer and into production.

Risk Management and Design for High-Volume Manufacture:

- Lead system-level risk management to ISO 14971, linking use, design and process risks (including dFMEA and pFMEA) so that hazards arising from the consumable, its manufacturing process and the reusable hardware are traced to effective controls and test protocols.

- Ensure critical consumables are designed for high-volume manufacture: define Critical-to-Function (CTF)



characteristics and Critical Quality Attributes (CQAs), and work with Process Development to link them to Critical Process Parameters (CPPs), tolerances and process capability targets.

- Assess the system impact of design, material, supplier and process changes on safety, performance, yield and supply continuity.

- Ensure that all aspects of systems engineering are incorporated into the final product and its manufacturing process to meet regulatory requirements.

Design Control and Design Transfer:

- Work with programme owners to establish the system framework for each product (requirements hierarchy, architecture, interfaces and verification strategy) within a single company-wide design control process spanning Product Development, Science, Manufacturing, Clinical and Quality.

- Define design transfer requirements and readiness gates so that sensor, process and calibration evidence moves in a controlled way from R&D; into repeatable, validated, high-volume manufacture.

- Continuously assess and adapt the framework to address evolving user needs, volume and scale-up targets, and regulatory changes.

Systems Integration:

- Utilise modelling to achieve a comprehensive understanding of the entire product system, including the device, the consumable, the production line, factory calibration and data flows.

- Create visual models and interface definitions that transcend discipline and language barriers, improving collaboration and communication across the company.

- Own technical interfaces and integration with functions across VitalTrace, including:

- Science & Evidence: Sensor R&D;, formulation and preclinical/clinical evidence generation

- Operations & Manufacturing: microfabrication, Process Development/NPI, production, factory calibration and QC

- Quality, Regulatory and Supply Chain: design controls, supplier controls for critical materials and components, and submissions

- Technology & Product: electronics, mechanical, packaging and labelling engineering

- Software, firmware, data and cybersecurity

Verification and Validation

- Lead integration and product-level verification and validation of VitalTrace's products (single-use sensors, reusable electronic systems and software), including the NeoLink and DelivAssure ecosystems, under ISO 13485, ISO 14971, IEC 60601 and IEC 62304.

- Define verification strategies suited to high-volume consumables, including statistically justified sample sizes, multi-lot verification, shelf-life and lot-release acceptance criteria.

- Ensure design verification is linked to process validation (IQ/OQ/PQ)



and in-process and release QC testing, so that production output continues to meet the verified design.

- Work with Quality to maintain independent review and acceptance of V&V; evidence.

Traceability, Factory Calibration and Lifecycle

- Own end-to-end traceability from user needs through design inputs, design outputs, risk controls and verification, and into the Device Master Record and production controls.

- Provide systems engineering leadership for the factory calibration workstream, ensuring traceable data flows across manufacturing, QC, preclinical/clinical evidence and algorithm release.

- Use production data (yield, nonconformances, CAPA and complaints) to feed back into requirements, risk files and design improvements across the product lifecycle.

- Ensure rigorous traceability and documentation (DHF/DMR) to simplify regulatory submissions and audits.

General Duties

- Conducting research, performing diagnostics, and troubleshooting product, equipment and production issues, including structured root cause analysis.

- Promote a safe working environment by following OH&S; guidelines as well as implementing & closing out actions for the continual improvement of workplace safety.

- Assist with the development of junior team members within VitalTrace.

Skills and Experience

- Bachelor's or higher degree in Systems Engineering, Biomedical Engineering, Mechanical/Manufacturing Engineering, Electronics Engineering, Mechanical Engineering or a related field
- Comprehensive Systems thinking with the ability to see the big picture and intricate details of complex medical device systems that combine reusable hardware, software and single-use consumables
- Strong communication skills to facilitate collaboration across science, engineering, manufacturing, quality and clinical teams and stakeholders
- Should definitely have Electronics or Mechatronics projects experience
- Risk Management - proven ability to identify, assess, and mitigate design and process risks in medical device development (ISO 14971, dFMEA/pFMEA)
- Design for manufacture of high-volume critical consumables, including tolerance analysis, process capability (Cpk), statistical sampling, SPC and design of experiments
- Highly adaptable with the ability to iterate and modify system frameworks to meet evolving requirements
- Highly organised with the ability to manage multiple aspects of systems engineering concurrently across several programmes and functions
- Proven experience in medical device development with a focus on systems engineering, ideally including high-volume single-use or consumable products (e.g. biosensors, CGMs, IVD consumables)
- Familiarity with regulatory standards, especially in the context of the FDA (21 CFR 820), ISO 13485, ISO 14971, IEC 60601 and IEC 62304
- Experience with design transfer and process validation (IQ/OQ/PQ) in a regulated manufacturing workplace
- Experience with Model-Based Systems Engineering tools and methodologies

📌 Systems Engineer (Malaga)
🏢 VitalTrace
📍 Malaga