Principal Software Systems Engineer – Medical Devices

ITMC Systems, Inc; Raleigh (NC); On-site; USD 100,000 - 130,000; Full time

Job summary

A technology solutions firm is seeking a Principal Software Systems Engineer in Raleigh, North Carolina. In this role, you will implement best practices in software development, provide technical leadership to an R&D team, and develop innovative solutions for complex challenges. The ideal candidate will have a Bachelor's degree with 5 years of experience or a Master's with 3 years, especially in medical devices or regulated industries. This position emphasizes Agile methodologies and risk management, making strong communication and documentation skills essential.

Qualifications

• 5+ years of experience with a Bachelor's degree in engineering or related field, or 3+ years with a Master's degree.
• Experience with regulated products in the medical devices/biotechnology industry is preferred.
• Familiarity with electro-mechanical devices is preferred.
• Expertise in Agile environments and product backlog management.
• Knowledge of medical device cybersecurity design paradigms is a plus.
• Experience with cloud-based applications (AWS/Azure) is preferred.
• Exceptional communication skills and strong documentation skills.

Responsibilities

• Drive best practices in software systems development and product lifecycle.
• Provide technical leadership to an R&D team.
• Develop innovative solutions to software challenges.
• Assist in architectural contributions for digital applications.
• Translate user needs into functional requirements.
• Maintain compliance with Quality Management Systems.
• Lead risk analysis activities based on ISO 14971.
• Collaborate on verification and validation plans.
• Conduct testing to ensure product quality.
• Support Agile/Scrum planning and execution.
• Collaborate with stakeholders to enhance processes.

Skills

Agile methodologies

Technical leadership

Complex problem solving

Requirements management

Risk management

Documentation skills

Stakeholder collaboration

Education

Bachelor's degree in engineering or related field with 5+ years of experience

Master's degree with 3+ years of experience

Tools

Agile/Scrum tools

Requirements management tools

Risk management tools

Job description

A technology solutions firm is seeking a Principal Software Systems Engineer in Raleigh, North Carolina. In this role, you will implement best practices in software development, provide technical leadership to an R&D team, and develop innovative solutions for complex challenges. The ideal candidate will have a Bachelor's degree with 5 years of experience or a Master's with 3 years, especially in medical devices or regulated industries. This position emphasizes Agile methodologies and risk management, making strong communication and documentation skills essential.