Computer System Validation Csv Remote Jobs in Colorado

About the Opportunity

We are seeking a software verification and validation (V&V) engineer to ensure the quality of cutting-edge products to meet all defined system and subsystem level requirements and are safe, effective, and compliant for their intended clinical use. This role plays a critical part in supporting regulatory submissions and product releases by planning, executing, and documenting comprehensive V&V activities in accordance with FDA regulations, ISO 13485, IEC standards, and other applicable regulatory and quality system requirements.

Key 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
• Statistical Analysis and Exploratory Data Analysis (e.g., descriptive statistics, regression, visualization)
• Developed test methods and verification protocols for software product
• Create and maintain test master plans, schedules, and resource allocation for multiple device programs.
• Participate in software development sprint cycles by supporting the software development team through attending SCRUMs, design reviews, code reviews and providing feedback on software verification and validation deliverables.
• Collaborate with cross-functional teams to understand requirements and translate them into comprehensive test plans and protocols
• Data Governance, Access Controls, and PHI Data Handling

Responsibilities

Required Qualifications & Skills

• 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.
• Experience with non-product software development
• Strong programming skills in Python across data science, statistical analysis, big data and ML stack
• Experience with quality engineering under quality system regulations, including but not limited to 21 CFR Part 820, ISO 14971, IEC 62304, QSR, ISO 13485, MDSAP and/or MDD/MDR
• Expertise in issue tracking and project management tools like JIRA
• Strong understanding of the software development life cycle and testing life cycle.
• Excellent problem-solving, analytical, and critical thinking skills
• Ability to work collaboratively in a remote-first team environment and to communicate effectively with Product Managers, Engineers, and other stakeholders

• Prior experience in utilizing AWS Cloud Services or an equivalent enterprise cloud service provider
• Experience in Class II or Class III medical devices is preferred
• Experience in Cardiovascular imaging system is a major plus

OUR COMPANY IS AN EQUAL OPPORTUNITY EMPLOYER. We do not discriminate on the basis of race, color, national origin, ancestry, citizenship status, protected veteran status, religion, physical or mental disability, marital status, sex, sexual orientation, gender identity or expression, age, or any other basis protected by law, ordinance, or regulation.

Job duties, activities, and responsibilities are subject to change by our company.

The base salary range for this role varies by location and is aligned to market benchmarks.

• Candidates located in higher-cost labor markets, including California, Washington, New York, New Jersey, Connecticut, Massachusetts, and Washington, DC represent the middle to high end of the range, while candidates located in all other U.S. locations represent the low to middle end of the range.
• Final compensation is determined based on location, experience, skills, and internal equity.

This role is eligible for a 15% target annual bonus, resulting in the following base salary and Total Target Compensation (TTC) ranges:

• Base Salary: $153,000 - $179000
• TTC: $176,000 - $206,000

*Total Target Compensation (TTC): Total Cash Compensation (including base pay, variable pay, commission, bonuses, etc.) Additionally, stock options, paid benefits, and employee perks are part of your total rewards.