We are seeking a highly skilled and motivated Senior Embedded Software Engineer to lead the design, development, and maintenance of cutting-edge software solutions for our In Vitro Diagnostic (IVD) medical devices. In addition to developing new software, this role will be responsible for maintaining existing product codebases, ensuring continued compliance with regulatory standards, and driving software maintenance planning and execution. The ideal candidate will have experience in medical software development, working knowledge of regulatory standards applicable to IVD Medical Devices, and a passion for delivering high-quality, reliable software that meets the stringent requirements of the healthcare industry. This role requires close collaboration with internal and external cross-functional teams, including hardware engineers, clinical scientists, and regulatory experts, to ensure successful product development and product lifecycle management.
Key Responsibilities:
- Software Design & Development: Lead the architecture, design, and implementation of embedded software and applications for IVD medical devices, ensuring compliance with industry standards.
- Software Maintenance: Oversee the maintenance of on-market product codebases, ensuring continued product software lifecycle maintenance planning, regulatory compliance, and alignment with customer needs.
- Maintenance Planning & Execution: Lead software maintenance planning efforts, including bug fixing, performance improvements, and product updates, while ensuring thorough documentation and testing to meet regulatory and quality standards.
- Regulatory Compliance: Ensure software development and maintenance activities adhere to applicable regulatory standards (e.g., IEC 62304, ISO 13485, FDA 21 CFR Part 820) and participate in the preparation of technical documentation for regulatory submissions.
- Collaboration: Work closely with cross-functional internal teams, including R&D, Quality, regulatory, and leadership in addition to external contractors and consultants to understand requirements and develop software solutions that meet clinical and technical needs
- Testing: Develop and execute unit tests, integration tests ensuring the software meets performance and safety requirements.
- Code Review & Mentorship: Provide technical leadership, conduct code reviews, mentor junior engineers, and promote best practices in software development.
- Continuous Improvement: Identify opportunities for improving development processes, tooling, and workflows to increase efficiency and product quality.
- Project Management: Contribute to project planning, task estimation, and risk management. Ensure timely delivery of software components in alignment with project milestones.
Qualifications:
- Education: Bachelor’s or master’s degree in computer science, Software Engineering, or a related field.
- Experience:
- 6+ years of software development experience, with at least 4 years in medical device or regulated industry (preferably IVD).
- Experience maintaining and enhancing software for on-market products, with a focus on long-term reliability and compliance.
- Strong experience with embedded systems development, real-time operating systems (RTOS), and microcontrollers.
- Proficiency in programming languages such as C, C++, Python, or other relevant languages.
- Independently setup and maintain development environments for ARM products and an IAR embedded workbench
- Familiarity with medical device software development lifecycle, including design controls, risk management, and verification/validation activities.
- Skills:
- Knowledge of regulatory standards like IEC 62304, ISO 14971, and FDA 21 CFR Part 820 and the FDA’s Guidance on cybersecurity
- Strong understanding of software development methodologies (Agile, Scrum) and issue tracking tools (Jira)
- Excellent problem-solving skills and ability to work in a fast-paced, collaborative environment.
- Strong communication skills and ability to interact with both technical and non-technical stakeholders.
Preferred Qualifications:
- Experience in developing and maintaining software for diagnostic devices, laboratory equipment, or other healthcare technologies.
- Familiarity with cybersecurity standards (e.g., FDA cybersecurity guidance) in medical device software.
