Embedded Engineer

MUST HAVES:

• Bachelor’s degree in computer engineering, computer science, electrical engineering or related field
• Experience within security/ cybersecurity – aka how to create/develops security processes to protect sensitive data
• 3-5 (can vary) years of experience in product-related software engineering experience within a heavily regulated industry (auto, aerospace, med device, pharma etc.)
• Azure DevOps (or similar software) – for creating and auditing requirements, version control, reporting, requirements management, etc.
• C#, C , .NET (do not need to be super strong coding – just need to understand)

PLUSSES:

• Familiar with Linux-based environments
• Experience with electronic Quality Management Systems (eQMS) some software quality system
• Experience interfacing with electronics via RS232 and network technologies
• Connecting devices to the network
• FDA and ISO regulations
• Experience in a healthcare, medical devices, or clinical setting
• Master of Science in an IT or engineering discipline

Day to Day:

Insight Global is seeking an Advanced Quality Software Engineer for a hybrid (3x a week) opportunity at one of our largest Medical/Healthcare Device clients. This person will lead product development quality initiatives through identifying, investigating, planning, and conducting activities aimed at insuring robust and quality design of software for medical devices.

This individual will act as the SME for the team on the quality of the product’s software and will drive software quality, reliability and cybersecurity product and process improvements.

ESSENTIAL/PRIMARY DUTIES:

• Actively involved in creating, reviewing, and approving documentation related to the engineering Product Realization Process (PRP)
• Ensures the design and subsequent design changes meet and are reviewed by the appropriate department resources to comply with the specified regulatory standards
• Leads or participates in software reviews and qualification activities
• Participates in development and updates of Risk Management documentation and FMEA documentation
• Reviews and provides feedback on Verification and Validation Plans
• Supports creation and updates to Problem, Cause, Resolution code process
• Stays abreast of upcoming regulations and requirements to product cybersecurity
• Leads in the implementation of electronic Quality Management Systems (eQMS) and Software Development Life Cycle (SDLC) processes, including Quality System software validations