Sr. Principal Software Systems Engineer - Relocation Assistance
Core
Senior Principal Software Systems Engineer developing regulated digital applications and connected ecosystems for Infusion Pump Platforms in the medical device industry.
Role type
Senior Principal Software Systems Engineer (Regulated Medical Devices)
Builds
Digital applications and connected ecosystems for Infusion Pump Platforms
Domain
Medical Devices / Biotechnology / Regulated Software
Required skills
Systems Engineering, Requirements Management, Risk Management (ISO 14971), Agile/Scrum, Regulatory Compliance (ISO 13485, IEC 62304), Technical Leadership, Architecture Design, Verification and Validation, Cloud-based Digital Applications, AI/ML paradigms, Electro-mechanical devices knowledge
Preferred skills
Cloud-based digital applications (AWS/Azure), AI/ML implementation, Medical device cybersecurity design
Technologies
AWS, Azure, Agile/Scrum, ISO 13485, IEC 62304, ISO 14971
Responsibilities
Drive best practices in software systems development and product lifecycles using Agile PDLC/SDLC and Systems Engineering methodologies; 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 ensuring compliance with QMS and regulatory frameworks; Lead ISO 14971-based risk analysis activities; Collaborate on verification and validation plans; Conduct ad-hoc testing of software systems; Enforce Agile/Scrum planning execution; Drive collaboration with internal and external stakeholders; Interface with manufacturing and field service staff during design transfer; Address product complaints and issues with impact assessments; Uphold compliance with product development process and quality system standards.
Seniority
Senior, hands-on IC with strategic leadership
