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.
Responsibilities
- Assisting with the preparation of chemical solutions.
- Perform prototype production rigorously following established Work Instructions (WI) and standard operating procedure (SOP) documents.
- Perform in-process Quality Control testing and electrochemical data analysis.
- Collaborate with cross-functional teams in the execution of manufacturing process research and development (R&D) initiatives.
- Assist in the engineering development of new product lines, materials, and methods, contributing technical insights from a production perspective.
- Participate in process and product verification and validation (V&V) testing, including test setup, data collection, documentation, and reporting.
- Help to translate engineering and R&D findings into scalable production protocols and improvements to existing manufacturing processes.
- Work alongside other engineers, electrochemists, and scientists to develop improved production processes and methods.
- Involvement in updating and creating new standards of operations (WIs & SOPs) for ISO certification.
- Obtain principle knowledge of medical device manufacturing standards and regulations (ISO 13485 and 9001 in particular).
- Record ‘no red flag’ after ISO and Treatments/Methods laboratory audits.
- Select and set up the required lab equipment for tests, experiments, and analyses.
- Conduct lab tests for qualitative and quantitative analyses.
- Maintain experimentation records to ISO 13485 standards.
- Manage inventory for production materials and lab supplies.
- Support preparation for regulatory audits and inspections.
Required Qualifications & Experiences
- Diploma in Laboratory Technology, Biomedical Science, Engineering Technology, or a related technical field.
- Minimum of 2 years as a production laboratory technician.
- Experience with electrochemistry-based biosensor production is preferred.
- Experience with wet-chemistry production lab is preferred.
- Profound knowledge of Good Laboratory Practice (GLP).
- Familiarity with Quality Assurance compliance, especially ISO 13485 and/or ISO 9001 standards
Preferred Skills
- Demonstrated ability to manage tasks efficiently.
- Exceptional attention to detail, complemented by keen observational skills.
- Proven capacity to follow detailed instructions and sustain focus over long periods.
- Adept at identifying and implementing improvements for better quality, efficiency, and safety.
- Skilled at both independent and collaborative work with team members.
- Excellent ability to engage, contribute, and collaborate across multiple teams.
- Proficiency in QC testing, particularly with electrochemical data analysis.
- Competence in creating and updating Work Instructions & SOPs.
- Expertise in selecting, setting up, and utilizing lab equipment.
- Ability to decipher test outcomes and draft comprehensive technical documentation.
- Experience in tasks such as cutting, soldering, and crimping cables.
- Interest or experience in process engineering, V&V testing, and production-scale R&D is a plus.
- Proactive, hands-on, and committed to continuous improvement in manufacturing quality.
Why Join VitalTrace?
- Be part of a mission-driven company improving maternal and fetal health outcomes.
- Work with cutting-edge electrochemical medical technology.
- Collaborative team environment with opportunities for growth and learning.
