Immediate need for a talented
Engr 3, Systems . this is a
05-06 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.
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, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration
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