Principal Software system Engineer (Medical Device)

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

As a Principal Software Systems Engineer, your responsibilities will include:

Driving Best Practices: Implement and champion best practices in software systems development and product lifecycles, utilizing Agile PDLC/SDLC and Systems Engineering methodologies in collaboration with development and verification teams.

Technical Leadership: Provide guidance, mentorship, and technical leadership to a distributed R&D team, fostering a culture of innovation and excellence.

Complex Problem Solving: Develop innovative technical solutions to complex software system challenges, delivering high-quality results within tight deadlines.

Architectural Contributions: Assist in establishing robust system and software architectures for digital applications, ensuring alignment with established design inputs.

User Needs Translation: Identify and capture user needs for digital applications, translating them into functional and non-functional system requirements. Lead cross-functional teams to ensure these needs are effectively integrated into system requirements.

Documentation and Compliance: Write, maintain, and own system-level and software-level design inputs/requirements, ensuring compliance with established Quality Management Systems (QMS) and regulatory frameworks. Work with established requirements and risk management SW tools, and develop subject matter expertise in these tools.

Risk Management: Lead ISO 14971-based risk analysis activities, from identifying inherent hazards to implementing effective mitigation strategies.

Verification and Validation: Collaborate with verification engineers to define test strategies for system and software verification and validation plans, utilizing requirement tracing methods.

Hands-On Testing: Conduct ad-hoc testing of in-development and developed software systems to ensure ongoing product quality.

Agile Execution: Enforce and support teams in executing Agile/Scrum planning, including estimating, scheduling, and completing committed tasks.

Stakeholder Collaboration: Drive collaboration with internal and external stakeholders to enhance processes, practices, and technical mentorship, transforming software requirements into effective test architectures.

Design Transfer Process: Interface with manufacturing, field service, operations, and customer training staff throughout the design transfer process.

Issue Resolution: Lead/assist in technical investigations for field issues and product complaints, with appropriate impact assessments on requirements and risks.

Qualification:

To thrive in this role, you should possess:

A Bachelor’s degree in an engineering discipline with 5+ years of experience, or a Master’s degree with 3+ years of experience.

Proven experience with regulated products and connected systems in the medical devices/biotechnology industry preferred.

Familiarity with electro-mechanical devices is preferred.

Expertise in requirements management, risk management, and development in an Agile environment, including experience in creating and maintaining product backlogs.

Knowledge of implementing and enforcing medical device cybersecurity design paradigms is a plus.

Experience with cloud-based digital applications (e.g. SaaS/PaaS/IaaS environments with AWS/Azure or similar CSPs) is preferred.

Exceptional oral and written communication skills.

Strong documentation skills and experience in a regulated industry.