Sr. Software Systems Engineer
Core
Senior Software Systems Engineer developing regulated digital applications and connected ecosystems for Infusion Pump Platforms in the medical device industry.
Role type
Senior IC software systems engineer (regulated medical devices)
Builds
Digital applications, connected ecosystems, and software systems for infusion pump platforms
Domain
Medical devices / Biotechnology / Regulated software
Required skills
Requirements management, Risk management, Agile/Scrum execution, Systems engineering methodologies, Regulatory compliance (ISO 13485, IEC 62304, ISO 14971), Cloud-based digital applications, Electro-mechanical device familiarity, Medical device cybersecurity design paradigms
Preferred skills
AI/ML implementation in digital applications, SaaS/PaaS/IaaS environments (AWS/Azure)
Technologies
AWS, Azure, Agile/Scrum, ISO 13485, IEC 62304, ISO 14971
Responsibilities
Implement best practices in software systems development and product lifecycles, Provide technical leadership and mentorship to distributed R&D teams, Develop innovative technical solutions to complex software system challenges, Establish robust system and software architectures for digital applications, Translate user needs into functional and non-functional system requirements, Write and maintain system-level and software-level design inputs/requirements, Lead ISO 14971-based risk analysis activities, Collaborate on verification and validation plans, Conduct ad-hoc testing of software systems, Enforce Agile/Scrum planning and execution, Drive collaboration with internal and external stakeholders, Interface with manufacturing and field service staff during design transfer, Address product complaints and issues promptly, Uphold compliance with product development process and quality system standards
Seniority
Senior, hands-on IC
