Senior Clinical Engineer

Vor 6 Tagen

Town Of Cambridge, Österreich VeinTech Vollzeit

Add expected salary to your profile for insights

As a Senior Clinical Engineer within VeinTech you will play a pivotal role in bridging the gap between engineering and clinical practices. You will be responsible for ensuring that the medical device meets regulatory standards, is safe to use while also contribute to improving healthcare outcomes for patients. This role requires a deep understanding of both engineering principles and clinical applications within the medical device industry. 

Key Responsibilities: 

Clinical Integration & Evidence: Scoping, designing, planning and executing evidence generating studies including but not limited to pre-clinical and clinical studies. 

Human Factors & Usability: Optimize the design and usability of devices, systems, and interfaces to enhance user experience and safety by applying principles of cognitive psychology, ergonomics, and user-centered design. 

Design Validation Process: Collaborate with healthcare professionals (doctors, nurses, technicians) to understand clinical needs and translate them into technical requirements for medical device development. 

Risk Management: Conduct risk assessments and hazard analyses to identify and mitigate potential risks associated with medical devices throughout their lifecycle. 

Regulatory Compliance: Ensure that all medical devices meet regulatory requirements and maintain compliance throughout the development process. 

Testing and Validation: Plan and oversee clinical studies and testing procedures to validate the performance, safety, and efficacy of medical devices. Validation activities including packaging & labelling, shelf life, sterilization and biocompatibility validation.

Documentation: Prepare and maintain detailed technical documentation, including design specifications, test protocols, and reports for regulatory submissions.

Training and Support: Provide training and technical support to healthcare professionals on the use of medical devices, including troubleshooting and addressing usability issues. Development of IFU content and other training materials. 

Must Have: 

Minimum Bachelor’s Degree in Biomedical, Mechanical or Electronic Engineering or in a technically related field. 

Minimum of 6 years of relevant experience within the medical device industry, or advanced degree with a minimum of 4 years relevant experience. 

Qualified candidates must be legally authorized to be employed in Perth, Australia. 

Nice to Have 

In-depth knowledge of medical device industry and the application of various human factors/usability engineering principles and tools in the design, development, and evaluation of medical device products. 

Experience integrating human factors engineering into a systems engineering process as well as previous experience conducting formative and summative usability studies 

Ability to quickly understand and become proficient in domain knowledge. 

Ability to work independently with limited guidance and develop comprehensive plans and solutions. 

Strong understanding of medical device design principles, FDA regulations, risk management (ISO 14971), quality management systems (ISO 13485) and product development processes based on FDA Guidance and IEC 62366. 

Your application will include the following questions:

Which of the following statements best describes your right to work in Australia?

How many years' experience do you have as a Clinical Engineer?

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