System Engineering
- Define system architecture and allocate system requirements to software components
- Develop and maintain system requirements (SYS -> SRS)
- Ensure traceability from system to software
Software Lifecycle Management
- Support software development in compliance with IEC 62304
- Participate in software architecture, design reviews, and verification planning
- Drive requirement decomposition and interface definitions
Risk & Safety
- Perform system-level risk analysis in accordance with ISO 14971
- Define software safety classification (A/B/C)
- Ensure mitigation measures are correctly implemented and verified
Verification & Validation
- Define system and software verification strategies
- Support integration, system testing, and validation activities
- Ensure test traceability to requirements
Cross-functional Collaboration
- Work with hardware, software, quality, and regulatory teams
- Interface with product management and stakeholders
- Support audits and regulatory submissions
Compliance & Documentation
- Ensure compliance with:
- ISO 13485 (QMS)
- IEC 62304 (Software lifecycle)
- IEC 62366 (Usability)
- Cybersecurity standards (e.g., IEC 81001-5-1)
- Maintain technical documentation (architecture, interface specs, etc.)
Functional Knowledge：
- Familiarity with:
- Software architecture patterns
- Integration & debugging
- Understanding of:
- Software lifecycle processes
- Agile / V-model
Business Expertise:
- Knowledge of software life cycle standards IEC 62304 is required
- Knowledge of quality management standards (e.g. ISO 13485) would be preferred
- Experience with SaMD / embedded medical device would be preferred
Leadership:
- No supervisory responsivities in this role.
Problem Solving:
- Proficient in Problem solve skills to analyze complex issues.
- Proactive learning ability and willingness to acquire new knowledge.
Impact:
- Team players that can influence the environment for project success.
Interpersonal Skills:
- Explain complex information to others in straightforward situations
Education & Experience:
- 3–10+ years in software/system engineering Experience in regulated environments (medical preferred)
- Strong understanding of System engineering methodologies in Embedded or complex software systems
- Bachelor’s or master’s degree in:
- Software Engineering
- Computer Science
- Electrical Engineering
- or related field
Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.