Engr 3, Systems

Pyramid, Inc; San Diego (CA); Remote; USD 69,000 - 83,000; Full time

Benefits offered by this job

Health insurance (medical, dental, or视

Job summary

Pyramid Consulting, Inc. is seeking an Engr 3, Systems for an initial 6-month contract in San Diego, CA, with remote options. The role focuses on verification, validation, and regulatory compliance for medical devices and related cleaning products.

You will lead V&V activities, document requirements, and coordinate with cross-functional teams to ensure FDA 510(k) submissions and ISO 13485 alignment. Strong technical background in systems engineering is required.

Qualifications

• Bachelor's or Master's degree in biomedical or mechanical engineering or related field.
• 3–5 years in medical device R&D, verification and validation.
• Knowledge of FDA 510(k) submissions and ISO 13485.

Responsibilities

• Lead verification and validation activities for medical devices, ensuring FDA 510(k), ISO 13485, and 21 CFR Part 820 compliance.
• Document system and product requirements; manage changes through review, approval, and release.
• Develop and execute test protocols, plans, and reports for devices and cleaning/disinfecting products.
• Collaborate with cross-functional teams to meet regulatory and quality requirements.
• Prepare regulatory submissions, including FDA 510(k).
• Participate in design reviews and advise on manufacturability and testability.
• Maintain documentation of all verification and validation activities per quality system.
• Identify opportunities for process improvements and apply best practices in V&V.

Skills

510k

verification

medical device

Education

Bachelor/Master in Biomedical or Mechanical Eng

Job description

Immediate need for a talented Engr 3, Systems 0-5-06 Months contract opportunity with long-term potential and is located in San Diego, CA (Remote).

Job Diva ID: 26-11477

• Pay Rate: $50/hr - $60/hr.
• Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities

• 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.

Key Requirements and Technology Experience

• 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.

Our client is a leading Medical Device Industry.

Pyramid Consulting, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, colour, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.

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