Principal Software Systems Engineer

Intellectt Inc; Raleigh (NC); Hybrid; USD 120,000 - 150,000; Full time

Job summary

A healthcare technology firm is seeking a Senior Principal Software Systems Engineer responsible for developing innovative healthcare solutions within connected Infusion Pump platforms. The ideal candidate will lead best practices in software system development and possess over 10 years of experience in the field. This hybrid position requires experience with digital applications and excellent communication skills. You will collaborate with cross-functional teams and ensure compliance with regulatory standards.

Qualifications

• 10+ years of experience in software systems development.
• Subject matter expertise in requirements and risk management.
• Experience with digital applications connected to regulated devices preferred.

Responsibilities

• Drive implementation of best practices in software systems development.
• Provide technical guidance and feedback to team members.
• Develop technical solutions for complex software problems.

Skills

Requirements management

Risk management

Communication skills

Agile development

Education

Bachelor’s degree in engineering

Job description

Overview

Position Title: Senior Principal Software Systems Engineer

Assignment Duration: 12 months

Work Arrangement: Hybrid 3 days in office and 2 from home.

Position Summary:

As a Senior Principal Software Systems Engineer in the software organization, you will be responsible for developing innovative healthcare solutions and supporting development and sustaining activities within connected Infusion Pump Platforms to meet customer needs and regulatory standards.

Key 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.

Qualifications & Experience

• 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.