Job
Description
As a domain leader in the medical field, your role will involve leading development teams to create compliant, high-quality, and reliable software and systems that have a direct impact on patient care and diagnostics. Your responsibilities will include overseeing the design, development, and implementation of complex software solutions for medical devices and clinical laboratory systems. **Key Responsibilities:** - Lead the design and development of software architecture for clinical lab and medical device products, ensuring scalability, performance, and security. - Provide technical guidance, conduct code reviews, and ensure adherence to best practices and coding standards. - Drive innovation by evaluating and integrating new technologies, frameworks, and methodologies relevant to the medical field. - Troubleshoot and resolve complex technical issues related to system architecture, software defects, and integrations. - Oversee the development of software for laboratory information systems (LIS) and other lab-related platforms. - Ensure proper handling of clinical data, including sample tracking, test result reporting, and data management in compliance with regulations. - Integrate software with lab equipment, such as automated analyzers and PCR instrumentation, handling data acquisition and quality control. - Lead software development for embedded systems and user interfaces in medical treatment devices. - Ensure the software for therapeutic devices meets strict safety, reliability, and usability requirements. - Apply knowledge of device-specific standards to the software design and testing processes. - Ensure all development processes and products comply with relevant medical standards and regulations, such as FDA guidelines, ISO 13485, IEC 62304, and HIPAA. - Oversee documentation for regulatory submissions, including design specifications, risk analysis, and validation protocols. - Participate in quality assurance processes and internal audits to maintain high standards and accreditation. - Manage a technical team, including mentoring and training junior engineers, and conducting performance reviews. - Work closely with product managers, QA engineers, and clinical experts to translate requirements into effective technical solutions. - Communicate project status, technical risks, and progress to stakeholders, including both technical and non-technical audiences. - Foster a collaborative environment that promotes teamwork, quality, and continuous improvement. **Qualifications Required:** - 15+ years of experience in software development, with a minimum of 5+ years in a technical leadership or senior engineering role. - Proven experience in the medical domain, specifically with clinical laboratory systems or treatment devices. - Experience working within regulatory frameworks for medical devices and health information technology. - Expertise in programming languages such as C++, C#, Java, or Python. - Deep understanding of software development life cycles (SDLC) and methodologies (e.g., Agile). - Proficiency in designing and building scalable, secure, and resilient software systems. - Experience with relevant technologies like laboratory information systems (LIS), Electronic Medical Records (EMR), and data analysis tools. - Strong understanding of clinical laboratory workflows, data, and instrumentation. - Familiarity with medical device software development processes, risk management. **Additional Company Details**: This section is omitted as it is not present in the provided Job Description.,
