Senior Software V&V Engineer, Imaging Systems
New
Most of our teams work remotely and have access to our offices in Denver, Colorado, New, York, New York, Dallas, Texas, and Lisbon, PortugalFull-TimeSenior
Salary153,000 - 179,000 USD per year
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Job Details
- Experience
- 5+ years
- Required Skills
- PythonMachine LearningJiraData science
Requirements
- 5+ years equivalent work experience in medical imaging industry (Product Development, Quality).
- Bachelor's or Master's degree in Computer Science, Information Technology, or related field.
- Strong programming skills in Python (data science, statistical analysis, big data, ML).
- Experience with quality engineering under regulations (21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP, MDD/MDR).
- Expertise in issue tracking and project management tools like JIRA.
- Strong understanding of software development life cycle (SDLC) and testing life cycle.
- Excellent problem-solving, analytical, and critical thinking skills.
- Ability to work collaboratively in a remote-first team environment.
- Experience with non-product software development.
Responsibilities
- Develop and lead the Design Verification and Validation (V&V) plan in compliance with regulatory and quality system requirements (21 CFR Part 820, ISO 13485, ISO 14971).
- Define test strategies, protocols, and acceptance criteria for mechanical, electrical, optical, and system-level performance.
- Build complex data sets to be used in test.
- Perform statistical analysis and exploratory data analysis.
- Develop test methods and verification protocols for software products.
- Create and maintain test master plans, schedules, and resource allocation for multiple device programs.
- Participate in software development sprint cycles and provide feedback on deliverables.
- Collaborate with cross-functional teams to translate requirements into comprehensive test plans and protocols.
- Oversee data governance, access controls, and PHI data handling.
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