- Be responsible for Designing, developing, and maintaining embedded systems and software for medical devices.
- Work closely with cross-functional teams to ensure the successful integration of hardware and software components.
- Be responsible for optimizing system performance, ensuring reliability, and meeting project deadlines.
- Have a strong background in embedded systems, excellent problem-solving skills, and the ability to work independently as well as part of a team.
- Be expected to stay up to date with the latest industry trends and technologies and apply this knowledge to improve our products and processes.
- Independently conduct design change impact assessment, coordinate technical reviews of the changes, conduct failure analysis and potential risk impact assessment as part of a cross-functional Team.
- Translate user and business requirements into detailed product requirement specifications and design specifications.
- Apply design controls with extensive knowledge of ISO 13485, ISO 14971, IEC 62304, IEC 62366, and IEC 60601 for medical device development.
- Design and develop embedded systems and software for medical devices.
- Collaborate with cross-functional teams to integrate hardware and software components.
- Optimize system performance and ensure reliability.
- Troubleshoot and resolve issues related to embedded systems.
- Document design specifications, test procedures, and results.
- Stay current with industry trends and technologies.
- Participate in code reviews and provide constructive feedback.
- Mentor junior engineers and provide technical guidance.
- Contribute to the continuous improvement of development processes.
- Ensure compliance with industry standards and regulations.
- Manage project timelines and deliverables.
- Apply Six Sigma and Lean principles to enhance efficiency and minimize waste.
- Define integration and verification plans with experience in budgeting adequate resources and time for execution of the plans
- Create, maintain and release Design History File (DHF), Device History Record (DHR), Device Master Record (DMR)
- Conduct Technical reviews to root cause issues, perform tradeoff analysis, document key design considerations for future reference
