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# Engr 3, Systems

- **Company:** Pyramid Inc.
- **Location:** San Diego, CA, United States
- **Experience:** Experienced
- **Salary:** $104,000.0 - $124,800.0
- **Contract:** Permanent contract
- **Skills:** Adobe InDesign, Systems Engineering, Document Management Systems, Statistical Hypothesis Testing, Release Management, Software Tools, Requirements Management, Software Requirements Analysis, Verification and Validation (Software), Systems Integration
- **Published:** October 29, 2026
- **Apply:** https://www.careerbuilder.com/job-details/engr-3-systems-san-diego-ca--3a6a124e-2a88-4526-bd29-674bc80f440d

## About the Role

Employee Benefits, ISO (International Organization for Standardization), FDA (Food and Drug Administration), Maintain Compliance, Medical Equipment, Code of Federal Regulations, Validation Testing, Release Management/Engineering, Change Management, Team Lead/Manager, * Must have skills: - "501k", "verification", "medical device"

 * Bachelor's or master's degree in biomedical engineering, Mechanical Engineering, or a related field.
 * Minimum of 3-5 years of experience in the medical device industry, with a focus on R&D, verification, and validation.
 * In-depth knowledge of FDA 510k submission process and requirements.
 * Strong understanding of ISO 13485 and FDA 21CFR Part 820 regulations.
 * Firsthand experience with verification and validation processes for medical devices.
 * Experience with cleaning and disinfecting products for medical devices is highly desirable.
 * Strong analytical and critical thinking skills.
 * Excellent written and verbal communication skills.
 * Ability to work effectively in a team environment.
 * Meticulousness and strong organizational skills.
 * Proficiency in relevant software tools and technologies.
 * A strong technical background and experience within systems engineering in the medical device industry (Translation of User/Business Needs to System Requirements, Requirements Management, System Architectural Development, Functional Modeling, Systems Integration, Statistical Test Design, Verification and Validation, Hazards Analysis, and Failure Modes Effects Analysis), and/or other engineering disciplines within the medical device industry.

## Description

* Lead verification and validation activities for new and existing medical devices, ensuring compliance with FDA 510k, ISO 13485, and FDA 21CFR Part 820 regulations.
 * Document system and product-level requirements; managing changes via team review, approval, and release process.
 * Develop and execute test protocols, plans, and reports for medical devices and cleaning/disinfecting products.
 * Collaborate with cross-functional teams to ensure design and development activities meet regulatory and quality requirements.
 * Prepare documentation and support regulatory submissions, including FDA 510k submissions.
 * Participate in design reviews and provide input on design for manufacturability and testability.
 * Ensure all verification and validation activities are properly documented and maintained according to company quality systems.
 * Identify opportunities for process improvements and implement best practices in verification and validation.