Software Engineer
5 days ago
**Tasks**
- This is a global role that offers a unique opportunity to combine your coding expertise with a critical understanding of compliance and regulatory requirements.
- The Software Engineer is tasked with the responsibility to evaluate the safety and performance of software in medical devices and Software as a medical device as well as ensure that manufacturers comply with specific regulations, standards and legal requirements.
- You will be the bridge that ensures coding excellence meets the highest industry standards to shape the future of our world s innovative solutions.
- ** Key Responsibilities**:
- Safeguard the next generation of new medical products from software-related risks that can potentially harm patients and users.
- Be the fore-front expert in code quality and development best practices.
- Conducting thorough reviews of code for quality, correctness, efficiency, and adherence to regulatory requirements and coding standards.
- Identify performance and safety issues, logical errors, potential security vulnerabilities, and deviations from coding standards.
- Provide constructive feedback to manufacturers on compliance issues and deviation from best practices.
- Ensure software development process aligns with established compliance frameworks and guidelines.
- Deep understanding of technical documentation requirements for software-enabled medical devices, including but not limited to software specifications, design and architecture documents, risk management files, and software validation plans.
- Evaluating risk management files for software-enabled medical devices, including risk analysis, risk evaluation, and risk control measures to ensure appropriate identification, assessment, and mitigation of risks throughout the product lifecycle.
**Qualifications**
- Bachelor s or Master s degree in computer science, Software Engineering, Biomedical Engineering, or a related field
- At least 2 years of experience in software development (this includes the time for master s & PhD Thesis) with proficiency in programming languages. For example: Python, Java, C++, JavaScript, NodeJS.
- Preferably with 4 years exposure in the medical/ healthcare industry with knowledge on medical standards and regulations for example, ISO13485, EU Medical Device Regulation (MDR)
- Strong communication skills to communicate effectively with customers and internal teams, and articulate assessment findings clearly and professionally.
- Strong technical writing abilities to provide clear and concise feedback on the technical documentation and communicate assessment findings effectively.
- The ability to work independently and as part of a team and under pressure to meet deadlines and maintain confidentiality.
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