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A Newly created Field Clinical Engineer (all experience levels considered) has been created to help support an exciting Medical Technology start-up that is conducting in-human trials in Australia.
Company:
Our client is a high-growth, innovation-driven Medtech company conducting early-stage human clinical trials across Australia. Their focus is on a novel implantable device supported by proprietary access and monitoring equipment. The work involves first-in-kind technology and procedures, positioning this role at the forefront of medical device development.
Australia’s strong R&D ecosystem, including robust tax incentives, makes it a key hub for pre-commercial studies, with clinical work being completed locally prior to international expansion. Our client is expanding and seeking another Field Clinical Engineer (FCE) to join the technical clinical operations team and support the field execution of ongoing and upcoming trials.
The Role:
As part of the Field Clinical Engineering team, you would:
* Serve as a critical technical expert
* Be responsible for on-site clinical trial support, technical troubleshooting, physician and site staff training
* Feedback integration into the R&D cycle.
* The role bridges engineering, clinical, and operational functions
* Involves significant travel across study sites in major Australian Cities
* Willing to travel interstate frequently - sometimes 3-5 consecutive days during peak activity
* Self-directed learner with initiative - able to digest scientific literature and technical documentation quickly and deliver training and education appropriate to audience
* Flexible, resilient, and committed to high standards under dynamic and demanding conditions
Key Responsibilities:
Clinical Study Support
* Deliver on-site technical support during human studies, including device setup, calibration, and overnight monitoring sessions at trial sites
* Coordinate logistics and technical execution across multiple Australian study locations.
* Support study start-up tasks including site qualification, equipment delivery, and protocol compliance.
* Collaborate with CROs, clinical teams, and local investigators to ensure protocol fidelity and data quality.
* Identify and escalate field issues and contribute to continuous improvement of trial processes.
Technical Development & Feedback
* Interface with engineering and product teams to share field-based insights and usability feedback
* Work with complex equipment configurations, including third-party systems (e.g., ultrasound, recording tools, visualisation equipment)
* Assist in proof-of-concept validation and mechanism-of-action verification
* Document and report technical observations from the field to drive design iterations.
Training & Documentation
* Deliver hands-on and classroom-style training to site personnel on study procedures and device usage
* Support the development of training materials and standard operating procedures
* Review study documentation, such as protocols and technical manuals, and contribute to site readiness
Compliance & Data Integrity
* Ensure all activities comply with company SOPs, Good Clinical Practice (GCP), and applicable regulations
* Assist in capturing and reporting adverse events or device malfunctions according to protocol and regulatory requirements.
Qualifications & Experience:
* Tertiary qualifications in Biomedical Engineering, Clinical Engineering, Science, or similar technical or business field
* Proven experience in a hands-on clinical, technical support, or device-focused role —ideally in implantable device technologies.
* Strong interpersonal and communication skills
* Ability to work independently under high-travel and high pressure conditions
* Competency using MS Office and standard reporting/documentation tools.
Nice to Haves:
* Previous involvement in human clinical trials or experience supporting CRO-led studies
* Familiarity with anatomical systems, OR environments, or physiological monitoring technologies
* Background in EP, CRM, Neuromodulation, or other Class III devices is a strong advantage
* PhD, MEng, or significant practical experience in a highly technical clinical support role.
* A rare opportunity to work on cutting-edge medical technology in the pre-commercial development stage
* Meaningful input into device design and usability based on real-time field experience
* Exposure to a wide range of clinical sites and stakeholders across Australia
* The chance to influence the success of novel therapies before they enter global markets
* Above market remuneration package
* Opportunity to travel locally and globally
* Be part of a company that will make real impact on patient lives
Please Apply or contact Mehdi on 0450 968 468 to ask any questions you may have.
You will require unrestricted working rights in Australia to be considered for this position.
We thank you in advance for your interest!
Seniority level
* Seniority level
Associate
Employment type
* Employment type
Full-time
Job function
* Job function
Engineering and Research
* Industries
Medical Equipment Manufacturing and Hospitals and Health Care
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Perth, Western Australia, Australia 2 days ago
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