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