Cube Hub Inc - Principal Software Systems Engineer(Medical device)

Developer is needed in Raleigh, United States.

Client: Cube Hub Inc

Location: Raleigh, NC

Contract: Temporary, Contract

Job Description

This is where your work saves lives. This is a Contract - Hire role for USC or Permanent Resident only. 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.

What you’ll be doing:

- 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 the 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 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.

Requirements

What you’ll bring:

- Subject matter expertise in requirements management and risk management for complex, medically regulated, connected/interoperable systems 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.

Additional Information

Role is Hybrid: 3 days in the office and 2 from home.

Job Types: Contract, Temporary.

Benefits:

- 401(k)

- Dental insurance

- Health insurance

- Referral program

- Vision insurance

Application Questions

• Do you have 10+ years of experience in software systems engineering, preferably in a regulated industry?
• Have you worked on digital applications (SaMD, MDDS) connected to medical devices, such as infusion pumps or other clinical equipment?
• Are you familiar with medical device regulations and quality systems (e.g., FDA, ISO 13485) for software development?
• Do you have experience developing software in an Agile environment, including creating and maintaining product backlogs?
• Have you led risk analysis and requirements decomposition for complex, medically regulated systems?
• Have you mentored or led a team of software engineers, providing technical guidance and feedback?
• Are you confident in writing and communicating technical documentation to cross-functional teams, including clinical, commercial, and verification teams?
• What is your expected hourly rate?
• Are you a US Citizen or Green Card Holder? If on Visa, please mention the Visa Status.
• Are you ready for a background check and drug screen in accordance with the local law and regulations?
• Please confirm your email address and contact number.
• Cube Hub payroll is “Bi-Weekly”. Are you comfortable with the Bi-Weekly payroll policy?
• When would be a good time to call you? Please let us know a convenient time for us to contact you regarding this opportunity.

Work Location: In-person