Engr , Systems at Pyramid Consulting, Inc. in San Diego, California

Engr 3, Systems

Immediate need for a talented Engr 3, Systems. This is a 5-06 Months contract opportunity with long-term potential and is located in San Diego, CA (Remote). Please review the job description below and contact me ASAP if you are interested. 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 21
  
  CFR 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 21
  
  CFR 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, and we are currently interviewing to fill this and other similar contract positions.