Cloud Infrastructure Engineer (Verification Architect - Medical Systems)
Location: Morrisville, NC
Start Date: May 2025
Compensation:
Base Salary: Up to $142K/year (depending on experience)
Bonus: 10% of base salary
Work Environment:
Location: Based in Morrisville, NC 27560
Onsite Requirement: 3 days per week (no exceptions)
Education: Master's Degree in Computer Science, Electrical Engineering, Computer Engineering, or a related field, or equivalent experience.
Experience: At least 8 years of experience in verification development, with 5 years in senior or lead roles within regulated industries (preferably in medical devices).
Top Skills:
Industry Experience: Extensive experience in the Medical Device/Diagnostics industry is required. Experience in embedded software development is strongly preferred.
Technical Skills: Proficient in Agile, Azure DevOps, CI/CD, Source Code Management, and Software Life Cycle Development in a regulated environment.
Strong understanding of medical device regulatory standards (21 CFR Part 820, IEC 60601, IEC 62304, ISO 13485) and experience with system risk analysis, hazard analysis, and DFMEA.
Position Summary:
We are committed to advancing healthcare technologies and are seeking a Verification Architect for our Medical Systems team. This senior-level individual contributor role will specialize in vascular positioning systems, including AI/ML, application software, and embedded systems.
The ideal candidate will lead the design and execution of verification automation architecture for innovative medical devices, specifically imaging devices for catheters. You will play a key role in ensuring our products meet the highest quality standards, comply with medical device regulations, and deliver impactful solutions in the vascular division. This position offers an excellent opportunity to contribute to cutting-edge technologies in a highly visible and critical product area.
Key Responsibilities:
Lead Verification Automation Architecture: Design and implement automated test solutions using appropriate tools and languages (e.g., Test Frameworks) to ensure software quality.
Develop Verification Plans: Lead the creation and execution of system verification plans for medical devices, ensuring compliance with relevant regulatory standards and industry best practices.
Design Test Strategies: Develop and execute comprehensive test strategies and methodologies for system components across Software, Hardware, and Systems levels. Analyze system requirements and translate them into actionable test protocols.
Manage CI/CD Pipelines: Oversee the development and maintenance of CI/CD pipelines, ensuring smooth software integration and release processes for medical device systems.
Perform Manual Testing: Conduct manual testing and analysis, identifying and documenting defects or issues to ensure quality control and product reliability.
Risk Assessment and FMEA: Contribute to risk assessments, including Failure Modes and Effects Analysis (FMEA), to identify and mitigate potential risks throughout the product lifecycle.
Ensure Documentation Compliance: Maintain comprehensive documentation of verification activities, including test plans, reports, and defect tracking logs, ensuring compliance with regulatory requirements.
Compliance with Policies: Adhere to company policies, the Code of Ethics, and relevant Quality Systems to ensure all work aligns with industry standards and company regulations.
Education and Experience Requirements:
Education: Master's Degree in Computer Science, Electrical Engineering, Computer Engineering, or a related field, or equivalent experience.
Experience: At least 8 years of experience in verification development, with 5 years in senior or lead roles within regulated industries (preferably in medical devices).
Industry Experience: Extensive experience in the Medical Device/Diagnostics industry is required. Experience in embedded software development is strongly preferred.
Technical Skills: Proficient in Agile, Azure DevOps, CI/CD, Source Code Management, and Software Life Cycle Development in a regulated environment.
Strong understanding of medical device regulatory standards (21 CFR Part 820, IEC 60601, IEC 62304, ISO 13485) and experience with system risk analysis, hazard analysis, and DFMEA.
Proven track record of developing and deploying commercial products in a senior development or lead role.
Other Skills:
Strong critical thinking, problem-solving, and decision-making abilities.
Excellent verbal and written communication skills, with the ability to present complex ideas clearly.
Self-directed with the ability to work independently, while also thriving in collaborative team environments.
Demonstrated leadership skills and a commitment to delivering high-quality, reliable solutions.
Ability to adapt and thrive in a fast-paced, dynamic environment.