Harvey Nash · 7 hours ago
Senior Principal Systems Engineer – Digital Health & Medical Devices
Raleigh, NC
Contract
Hybrid
Senior Level, Lead/Staff
$76/hr - $78/hr
10+ years expHarvey Nash is seeking a Senior Principal Software Systems Engineer to develop innovative healthcare solutions for connected Infusion Pump Platforms. The role involves leading software systems development, collaborating with cross-functional teams, and ensuring compliance with regulatory standards.
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Hiring Manager
Mohammed Habeeb Hasan
Responsibilities
Drive the implementation of best practices in software systems development and product lifecycles in collaboration with development and verification teams, for Digital Applications that are part of infusion pumps ecosystem
Be a technical leader providing team members guidance and feedback on technical work
Develop technical solutions to complex software system problems and deliver high-quality solutions on tight schedules
Lead efforts with cross-functional team members (e.g. Commercial and Clinical) to document user needs and translate them to user needs into system requirements
Lead decomposition of system requirements into software subsystem requirements
Lead risk analysis activities for Digital Applications software from the capture of inherent hazards through mitigation implementation
Work with verification engineers to define test strategies for the development of verification and validation plans using requirement tracing methods
Participate in software design reviews for components or features
Perform product backlog and feature grooming/definition activities as part of Agile planning/execution
Drive collaboration with internal and external stakeholders and enable the team on better processes, practices and technical mentorship
Interface with manufacturing, service, and customer training staff through the design transfer process
Ensure compliance to the product development process and quality system
Qualification
Required
Bachelor's degree in an engineering discipline with 10 + years of experience
Subject matter expertise in requirements management and risk management for complex, medically regulated, connected/interoperable system of systems
Excellent oral and written communication skills
Excellent documentation skills
Preferred
Experience with Digital Applications (SaMD. MDDS) connected to regulated electro-mechanical devices in a clinical environment
Experience in a regulated industry
Experience with development in an agile environment with experience creating and maintaining product backlogs
Company
Harvey Nash
We’re Harvey Nash, and we build amazing technology and digital teams.
5001-10000 employees
H1B Sponsorship
Harvey Nash has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
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Trends of Total Sponsorships
2025 (62)
2024 (70)
2023 (121)
2022 (67)
2021 (3)
2020 (7)
Funding
Current Stage
Public CompanyTotal Funding
unknown1999-02-04IPO
Leadership Team
Ted Blumenberg
CFO
Michael Goldberg
Vice President, Strategic Partnerships
Recent News
2024-10-16
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