- Designing electrical circuits and systems for medical devices. - Developing prototypes of electronic components. - Working with software engineers to integrate electronic systems with computer software. - Ensuring that the electrical design meets the functional requirements of the medical device. - Conducting research to apply new technologies to medical device development. - Keeping up-to-date with advancements in medical tech and electrical engineering. - Innovating to improve existing medical devices or create new ones. - Performing electrical testing on medical devices to ensure safety and functionality. - Validating the performance of electrical systems in medical devices. - Troubleshooting and resolving electrical issues. - Ensuring that medical devices comply with industry standards and government regulations. - Understanding and applying relevant electrical codes and standards, such as IEC 60601 for medical electrical equipment. - Preparing documentation for regulatory submissions. - Working closely with other engineers to ensure the integration of all system components. - Collaborating with cross-functional teams, including manufacturing, quality, and regulatory affairs. - Communicating with suppliers and vendors to source electrical components. - Managing projects related to the development of electrical systems for medical devices. - Coordinating timelines, resources, and budgets for electrical engineering projects. - Leading or participating in design reviews and project meetings. - Providing technical support for medical devices during and after the production phase. - Creating and maintaining technical documentation. - Training staff and end-users on the proper use of electrical components in medical devices. - Identifying potential safety issues related to electrical systems and implementing risk mitigation strategies. - Ensuring that medical devices are safe for patients and comply with patient safety standards. - Analyzing performance data to identify opportunities for improvement in medical device electrical systems.- Implementing changes to enhance device performance, reliability, and cost-effectiveness.
1. Interface in cross functional teams to ensure the design meets all firmware, diagnostic and system level requirements 2. Participate in architecture definition, design reviews, requirements generation 3. Simulate and analyse design proposals, review results and provide recommendations on optimal design practices to other design engineers
1. Design, develop, and implement technical solutions related to hardware, while participating in project planning and scheduling 2. Provide technical leadership, manage non-technical elements (i.e., people and financials), and act as the primary contact for stakeholders 3. Lead the deployment of strategic technologies, and manage relationships with key vendors, stakeholders and partners
- Designing and coding software for medical devices and applications using appropriate programming languages and tools. - Developing software that can be integrated with hardware components of medical devices. - Implementing algorithms and data processing techniques specific to medical applications. - Writing and executing test plans to ensure the software functions correctly and meets all requirements. - Performing unit testing, integration testing, system testing, and acceptance testing. - Validating software for regulatory compliance and ensuring it adheres to industry standards such as IEC 62304. - Collaborating with stakeholders to gather and analyze software requirements. - Translating clinical and technical requirements into detailed software specifications. - Ensuring that software designs meet the needs of end-users, such as healthcare professionals and patients. - Creating and maintaining comprehensive documentation for software design, development processes, and testing procedures. - Preparing technical files for regulatory submissions and audits. - Providing ongoing maintenance and updates for existing software systems. - Troubleshooting and resolving software issues in a timely manner. - Offering technical support to users and internal teams. - Understanding and complying with regulatory requirements related to medical software, such as FDA regulations, HIPAA, and GDPR for data privacy. - Participating in risk management activities to identify and mitigate risks associated with software use. - Working closely with cross-functional teams, including hardware engineers, quality assurance specialists, regulatory affairs, and product managers. - Participating in code reviews and contributing to the continuous improvement of the development process. - Managing software development timelines and deliverables. - Ensuring projects are completed within budget and on schedule. - Keeping up-to-date with the latest software development tools, techniques, and industry trends. - Attending workshops, conferences, and training sessions relevant to medical device software engineering.