Senior Principal Software Systems Engineer
13 hours ago
About the Role
As a Senior Principal Software Systems Engineer, you will play a critical role in developing innovative healthcare solutions within Connected Infusion Pump Platforms. You will support both development and sustaining activities while ensuring compliance with regulatory and quality standards in a highly regulated medical environment.
Responsibilities
- Drive implementation of best practices in software systems development and product lifecycle management.
- Act as a technical leader, providing guidance, mentorship, and feedback to engineering teams.
- Develop and deliver high-quality technical solutions to complex system-level problems under tight timelines.
- Collaborate with cross-functional teams (Commercial, Clinical, Manufacturing, Service) to:
- Capture and document user needs
- Translate user needs into system and software requirements
- Lead decomposition of system requirements into software subsystem requirements.
- Lead risk analysis activities for Digital Applications software, including hazard identification and mitigation.
- Partner with verification engineers to define verification and validation strategies using requirements traceability.
- Participate in software design reviews for components and features.
- Support Agile development activities including backlog grooming, feature definition, and sprint execution.
- Drive collaboration with internal and external stakeholders while promoting improved processes and technical excellence.
- Support design transfer activities and interface with manufacturing, service, and training teams.
- Ensure compliance with product development processes and quality systems.
Qualifications
- Bachelor's degree in an Engineering discipline
- 10+ years of relevant experience in software systems engineering
Required Skills
- Subject matter expertise in requirements management and risk management for complex, medically regulated, connected/interoperable system of systems
- Bachelor's degree in an engineering discipline with 10 + years of experience.
- Experience with Digital Applications (SaMD. MDDS) connected to regulated electro-mechanical devices in a clinical environment preferred.
- Experience with development in an agile environment with experience creating and maintaining product backlogs.
- Excellent oral and written communication skills.
- Experience in a regulated industry preferred.
- Excellent documentation skills.
Equal Opportunity Statement
We are committed to diversity and inclusivity in our hiring practices and encourage applications from all qualified individuals.
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