Remote Medical Device Verification Engineer (FDA 510k)

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

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.