Engr 3, Systems

• 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.

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.

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).

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 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. By applying to our jobs, you agree to receive calls, AI-generated calls, text messages, or emails from Pyramid Consulting, Inc. and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here.