Medical Device Engineer - Verification and Validation

PlatinumAI is seeking experienced Verification & Validation Engineers to support medical device and combination product programs.

This is a contract-based role supporting engineering teams with execution of verification and validation activities in regulated environments.

Overview
We are seeking a highly motivated and detail-oriented Medical Device Engineer specializing in Verification and Validation (V&V) to join our innovative team. This role offers an exciting opportunity to contribute to the development and assurance of high-quality medical devices that meet rigorous industry standards. As a key player in our quality assurance process, you will ensure that products comply with regulatory requirements and internal specifications, driving excellence from design through manufacturing. Your expertise will help shape the safety, efficacy, and reliability of our medical solutions, making a meaningful impact on patient care worldwide.

Duties

• Develop, execute, and document verification and validation protocols for medical devices in accordance with industry standards such as ISO 13485, FDA regulations, and CGMP guidelines.
• Collaborate with cross-functional teams including design, manufacturing, and supply chain to ensure product quality throughout the development lifecycle.
• Perform root cause analysis on product failures or non-conformances using tools like Minitab and 8D methodology to identify corrective actions.
• Conduct risk assessments and failure mode effects analysis (FMEA) to proactively address potential issues early in the product lifecycle
• Support supplier management activities by qualifying vendors, reviewing supplier quality data, and ensuring compliance with standards such as AS9100, IATF 16949:2016, and ISO 9001.
• Lead process validation efforts utilizing APQP (Advanced Product Quality Planning), PPAP (Production Part Approval Process), and process engineering best practices to guarantee robust manufacturing processes.

Qualifications

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related field; advanced degrees preferred.
• Proven experience in verification and validation of medical devices or similar regulated industries.
• Strong knowledge of industry standards including ISO 13485, FDA regulations, and related quality systems.
• Familiarity with quality tools such as root cause analysis, FMEA, Minitab statistical software, and lean manufacturing principles.
• Mechanical knowledge combined with experience in manufacturing processes like assembly, sourcing, and supply chain management.
• Ability to interpret technical drawings using GD&T principles; experience with CAD tools is a plus.
• Excellent communication skills with the ability to work collaboratively across multidisciplinary teams while maintaining attention to detail. Join us to be part of a dynamic environment where your expertise will directly influence the safety and effectiveness of life-changing medical devices!

Pay: $75,000.00 - $100,000.00 per year

Work Location: Hybrid remote in Chicago, IL 60617

Salary : $75,000 - $100,000