Overview
On Site
Accepts corp to corp applications
Contract - W2
Contract - to 30/11/2026
Skills
Health Care
Lifecycle Management
IT Management
Mentorship
System Requirements
Risk Analysis
Requirements Traceability
Software Design
Estimating
Scheduling
Collaboration
Regulatory Compliance
Quality Management
Design Controls
End-user Training
Software Engineering
Systems Engineering
Mechanical Engineering
ISO 13485
Agile
Management
Risk Management
FMEA
Verification And Validation
Documentation
Communication
Leadership
Manufacturing
Medical Devices
Software Development
Embedded Software
SANS
Quality Assurance
WebKit
Job Details
Job Description Senior Principal Systems Engineer (Software) Infusion Pump Platforms
Overview
This role focuses on developing and sustaining software for Infusion Pump medical devices, delivering high-quality healthcare solutions that meet regulatory standards. You will lead system-level software engineering activities, guide cross-functional teams, and ensure compliance with medical device development processes.
Key Responsibilities
- Lead best practices for software systems development and lifecycle management.
- Provide technical leadership, mentorship, and review of engineering work.
- Develop solutions for complex software system challenges under tight timelines.
- Translate user needs (Clinical/Commercial) into system-level requirements.
- Decompose system requirements into software subsystem requirements.
- Lead software-related risk analysis (hazards mitigations).
- Define verification & validation strategies using requirements traceability.
- Participate in software design reviews.
- Support Agile planning: estimation, scheduling, backlog maintenance.
- Drive collaboration with internal and external stakeholders.
- Ensure compliance with quality systems and design control.
- Support design transfer to manufacturing, service, customer training.
Top Skills & Must-Haves
- 10+ years Engineering experience (Systems or Software Engineering).
- Strong systems engineering background (requirements, architecture, decomposition).
- Experience with electro-mechanical devices (highly preferred).
- Hands-on medical device / regulated industry experience (preferably FDA 21 CFR 820, ISO 13485).
- Experience in Agile development, backlog creation/management.
- Expertise in risk management (FMEA, hazard analysis, risk controls).
- Strong verification & validation planning, test strategies, traceability.
- Excellent documentation, communication, cross-functional leadership.
- Experience supporting design transfer, manufacturing & service functions.
Preferred Experience
- Infusion pumps, drug delivery systems, or other Class II/III medical devices.
- Software development background (embedded software, digital health apps).
- Working with cross-functional teams: clinical, commercial, regulatory, QA.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.