Senior Embedded Software Engineer
• Design and develop embedded software/firmware using C programming languages for new products or design changes of existing products.
• Lead/participate in software design & development, implementation and testing, troubleshooting and documentations for the pilot/engineering/V&V/production stages of medical devices
• Collaborate with stakeholders to develop software requirements specifications. Responsible for software implementation and integration, ensuring products are according to design requirements.
• Work closely with hardware and mechanical engineers to develop product software architecture and corresponding documentation, e.g.: technical specifications, UML diagrams, and code description.
• Lead/participate in software risk management, impact analysis, regression analysis, software verification and validation activities. • Work closely with cross functional teams or external suppliers e.g. Contract manufacturer or consultants.
• Work closely with design assurance, quality and regulatory teams to achieve company goals.
• 5+ years of embedded firmware development experience (preferably medical device software class B and C as per IEC62304 standard)
• Bachelor’s, master’s or PhD in electrical/electronic or computer science
• Demonstrated applied expertise in FDA requirements and medical device regulations including IEC 62304, ISO 13485, and ISO 14971.
• Experience working on connected medical devices (mobile and cloud supported devices). • Solid experience in preparing technical files for supporting regulatory submissions (including CE mark, US FDA)
. • Strong working knowledge of software development and configuration management tools (e.g., Jira, Git) • Excellent written, oral communication and documentation skills
Please send in your resume in MS Word format to [Click Here to Email Your Resume]
Manimalah Suppiah, EA License No : 06C4642, EA Reg No : R1105598
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