Job Description

Job Requirements
A domain leader with experience in the medical domain with a deep understanding of clinical laboratory processes, medical device technology, and relevant regulatory standards. He/She should lead development teams to build compliant, high-quality, and reliable software and systems that directly impact patient care and diagnostics.
He/She will oversee the design, development, and implementation of complex software solutions for medical devices and clinical laboratory systems. This role requires a blend of hands-on technical expertise, strategic leadership, and a thorough understanding of medical standards and regulations. The ideal candidate will mentor a team of engineers, guide technical decisions, and collaborate with cross-functional teams to deliver innovative and compliant medical products.
Roles and responsibilities:
Technical leadership and architecture

• 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.

Medical domain expertise:

• Clinical Laboratory Systems:

• 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.
• Treatment Devices:

• 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.
• Regulatory Standards:

• 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.

Team management and collaboration

• 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.

Work Experience
Experience:

• 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.

Technical Skills:

• 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.

Domain Knowledge:

• Strong understanding of clinical laboratory workflows, data, and instrumentation.
• Familiarity with medical device software development processes, risk management,

Soft Skills:

• Exceptional leadership, communication, and interpersonal skills.
• Strong analytical and problem-solving abilities with high attention to detail.
• Proven ability to work in a fast-paced, regulated, and collaborative environment

Skills Required