Qualitest Group is seeking a Systems Engineer with extensive experience in regulated medical software to join their remote team. The ideal candidate will have a strong background in systems engineering, particularly in software medical devices, and be adept at navigating regulatory environments
Job Summary
The role involves applying systems-thinking to the full lifecycle of regulated digital health software from concept to post-market surveillance.
Candidates must have deep fluency with the company's platform including microservices, cloud services, and APIs to anchor requirements and test strategies.
This position requires balancing modern Agile development practices with strict compliance expectations under FDA, ISO, and IEC frameworks.
Matching Summary
Match Score: 85
Qualitest Group is seeking a Systems Engineer with extensive experience in regulated medical software to join their remote team. The ideal candidate will have a strong background in systems engineering, particularly in software medical devices, and be adept at navigating regulatory environments.
Skills & Requirements
Must-have
7+ years regulated medical software experience
SaMD and digital health product shipping
Requirements ownership and traceability
ISO 14971 risk management expertise
IEC 62304 software verification experience
FDA and ISO regulatory framework knowledge
Nice-to-have
Agile or hybrid development environment
Cloud-native microservices architecture fluency
Human factors engineering IEC 62366-1
Cybersecurity threat modeling skills
Mentoring junior engineering staff
Cross-functional stakeholder leadership
Key Requirements
Bachelor's degree in Engineering or related field
7+ years systems engineering in regulated medical software
Experience shipping SaMD products through regulatory clearance
Proven track record in design controlled environments