Our partner is seeking a Reliability Engineer to join our Product Development team in Miami, Florida. Reporting to the Director of Reliability Engineering, this role will focus on enhancing product reliability, safety, and compliance to ensure our products meet customer expectations for quality and performance. The ideal candidate has experience in product risk management activities, verification and validation testing, and design controls for medical devices (ISO 13485). They will collaborate with cross-functional teams to drive compliance and reliability from early development through commercialization.

Responsibilities to include:

• Ensure product development team compliance with the company's Quality Management System (QMS), as well as ISO 13485, FDA 21 CFR Part 820 (QSR), and EU MDR requirements.
• Drive risk management activities (ISO 14971) and ensure they are properly conducted, documented, and maintained throughout the product lifecycle.
• Audit product requirements and claims definition throughout the development process
• Develop design verification & validation (V&V) test plans.
• Coordinate and execute product test protocols and reports with internal resources, supplier, or 3rd party labs.
• Participate in product design reviews, providing insights on safety, reliability and efficacy.
• Support internal and external audits related to product development, design controls and risk management.
• Support managing the reliability test laboratory, including coordinating equipment calibration, troubleshooting, and scheduling repairs.
• Collaborate with Engineering, Brand, and Regulatory teams to improve product design, reliability, and manufacturability.

 

What You Will Need

• B.S. or higher in Engineering, preferably in Mechanical or Biomedical Engineering.
• 4+ years of relevant experience as a Reliability Engineer, Verification Engineer, or Design Assurance Engineer in the product development of medical devices.
• Knowledge of ISO 13485, ISO 14971, FDA 21 CFR Part 820, and EU MDR regulations.
• Experience with design verification & validation (V&V), risk management (FMEA), and design controls.
• Strong organizational and time management skills to prioritize multiple projects effectively.
• Strong technical writing and verbal communication skills for documentation and cross-team collaboration.
• Experience in test method development, including test fixture design using 3D CAD software (e.g. SolidWorks).

Bonus experience:

• Hands-on experience designing, building and qualifying dynamic electro-mechanical test equipment and fixtures.
• Experience in Corrective and Preventive Actions (CAPA) to improve product safety and reliability.

Physical Requirements:

• Ability to stand, walk, and sit for extended periods.
• Ability to lift objects up to 50 pounds.
• Ability to work in a laboratory environment, including exposure to chemicals, biological materials, and hazardous waste.

Who You Will Work With

Our partner is an organization that values collaboration and community. As the Reliability Engineer, you will work closely with the Quality and Regulatory teams.

Posted On: Thursday, April 3, 2025